Download Background to Project - CSUSAP

Contents
Page
Background to Project
4
Screening and
intervention opportunity:
an example for metabolic
syndrome ............................................................................................................... 4
Diabetes and Cardiovascular Disease: Relationship to this Project
6
Health impacts of
diabetes and its
complications ........................................................................................................ 6
Diabetic Retinopathy ............................................................................................ 6
Cardiovascular Disease ........................................................................................ 7
Foot complications ............................................................................................... 7
Quality of life and health care
8
Impact of Early
Intervention on Quality
of Life for People with
Diabetes Complications ........................................................................................ 8
Assessment intervention strategies in rural/regional areas
9
Barriers to effective
screening and treatment ........................................................................................ 9
Strategies in assessment of complications of diabetes
10
Eye Screening ..................................................................................................... 10
Heart Assessment ............................................................................................... 10
Foot Assessment ................................................................................................. 11
A one-stop mobile health check for diabetes
12
References
13
Risk Management Plan
16
Diabetes Complications
Screening and Research ...................................................................................... 17
Standard Operating Procedures (SOP)
32
Venipuncture Technique
Using the Multisample
Vacutainer System .............................................................................................. 33
Blood Collection by
Finger Prick ......................................................................................................... 37
Manual Blood Pressure
Measurement ....................................................................................................... 38
Body Mass Index (BMI) ..................................................................................... 42
Use of Tiptherm ™ ............................................................................................. 43
Autonomic Nervous
System Function Tests
(Ewing Battery) ................................................................................................... 44
3-lead
Electrocardiogram
(ECG) 46
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
1
12-lead
Electrocardiogram
(ECG) 49
Risk Assessments
54
Venipuncture ...................................................................................................... 55
Electrocardiogram
(ECG) 56
Blood Pressure
Recording using a
Sphygmomanometer and
Stethoscope ......................................................................................................... 57
Blood Pressure
Recording using a
Digital Blood Pressure
Monitor ............................................................................................................... 58
Emergency Procedures
59
Cedar Floor Plan ................................................................................................. 60
Diabetes Complications
Screening Emergency
Response ............................................................................................................. 61
Hypoglycaemia
Emergency Response .......................................................................................... 62
Fainting Emergency
Response ............................................................................................................. 63
Student Screening Documents
64
Student
Acknowledgement
Statement ............................................................................................................ 65
Student feedback for
diabetes complications
screening ............................................................................................................. 66
Diabetes Complications Screening Forms
67
Information Sheet ............................................................................................... 68
Consent Form ..................................................................................................... 70
Participants Information ..................................................................................... 71
Participants Assessment
Results Feedback ................................................................................................ 73
To: General Practitioner
73
Diabetes Screening
Session - Stations. ............................................................................................... 75
Station Requirements: ........................................................................................ 76
Pathology Request Forms
77
Dorovitch Release Form ..................................................................................... 78
South West Pathology
Release Form ...................................................................................................... 79
Insurance
80
ECG Analysis
81
12-lead ECG
classification ....................................................................................................... 82
Analysing HR Intervals
with Chart 5 ........................................................................................................ 83
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
2
Downloading Files from
Mac Computers ................................................................................................... 84
Retinal Analysis
85
Digital Health Care
Software and Camera
Loading on to PC ................................................................................................ 85
Non- Mydriatic Camera ...................................................................................... 86
Saving Digital Eye Data
as JPG Files ......................................................................................................... 87
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
3
Background to Project
Diabetes mellitus is a growing health care problem in Australia with over two million
Australians expected to be diagnosed with diabetes by 2010. This equates to roughly 10%
of the population and increases the work-load on general practitioners. Cardiovascular
disease (CVD) remains the most important complication of diabetes. The annual
macrovascular event rate in the absence of risk factors for CVD (such as dyslipidemia,
hypertension, smoking, and obesity) is 2%. In the presence of a risk factor, this increases
to 5%, and if there is a history of a macrovascular event, the rate rises to 8%. In select
populations with low high-density lipoprotein cholesterol (HDL-C), the rate can be as high
as 11% per year.
Cardiovascular associated mortality accounts for 38% of all deaths. 16.4% of Australians
currently have CVD. Independent of diabetes, CVD will affect one in four Australians by
2051. CVD associated mortality accounts for 38% of all deaths. 16.4% of Australians
currently have CVD.
Of immediate concern is also the recognition that a constellation of symptoms, the
metabolic syndrome constitutes an increased risk of diabetes and cardiovascular disease.
Screening and intervention opportunity: an example for metabolic
syndrome
Outlined here is a summary of metabolic syndrome that highlights presentation and
screening requirements. Of interest here is that the identification of people with metabolic
syndrome can be part of a chronic disease management and intervention programme at
CSU with the possibility of various student cohorts including nursing, podiatry, pharmacy,
nutrition, physiotherapy/exercise physiology, occupational therapy and leisure and health
as well as medical imaging involved in screening and intervention. Many of these student
cohorts can be part of the screening and intervention through placement at the university
on any of the campuses or via tutorials, practical classes or workshops. This provides
multidisciplinary health care to all regions serviced by the Faculty and also reduces the
cost of placements that are incurred by some disciplines.
As such NSW Health, various publications from the Australian Diabetes Society and
Australian Heart Foundation and the American Diabetes Association (ADA) have
suggested that the reduction of macrovascular disease risk such as seen with metabolic
syndrome (Table 1) requires a multifactorial approach that addresses all risk factors,
including obesity and hypertension, in addition to dyslipidaemia, and makes the following
recommendations.
Table 1: Factors associated with metabolic syndrome
Metabolic syndrome is defined if three of the listed features are present

Abdominal obesity (waist > 101 cm in men or > 89 cm in women);

Elevated triglycerides (> 8 mmol/L);

Decreased HDL-C (< 2 mmol/L in men and < 3 mmol/L in women);

Hypertension (blood pressure > 130/85 mm Hg); and

Elevated fasting blood glucose (> 6 mg/dL).
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
4
Individuals who present with 3 or more of these features are at elevated risk for
developing CVD. These features can be determined by the chronic disease management
clinic by including point-of-care testing for cholesterol unless a result is available through
the general practitioner or pathology service.
The recommended strategy for managing patients with the metabolic syndrome is to
reduce underlying causes (ie, obesity and physical inactivity) and to treat nonlipid and lipid
risk factors. Again apart from medication management, the chronic disease management
clinic can contribute meaningful intervention and health care.
I list some additional relevant screening and intervention possibilities below:









Identification of CV risk factors such as hypertension, obesity, smoking and alcohol
as well as age, family history and blood sugar levels
Diabetes and diabetes risk factor – increased blood sugar levels, age, ethnic
background, family history, gestational diabetes and ovarian cancer
Lifestyle counselling - Smoking abstinence, exercise, weight control, blood
pressure control and diet as well as medication review.
Medical imaging is also relevant to this as it can be used to identify asymptomatic
cardiovascular disease and confirm 12-lead or 3-lead ECG assessment.
Pharmacy medication review
Nutrition counselling
Nursing reviews
Occupational Therapy – quality of life and activities of daily living
Physiotherapy - exercise
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
5
Diabetes and Cardiovascular Disease: Relationship to this Project
Given the increased incidence of diabetes nationally and internationally over the last 2
decades, a vast amount of literature in the area has been generated. The review below
addresses the literature sets relating to this project namely: health impacts of diabetes and
its complications; assessment intervention strategies in rural/regional areas; and, the
experience of people and their families living with diabetes in rural regional communities.
Health impacts of diabetes and its complications
In 2002, an estimated 780,000 Australians had diabetes, with numbers exceeding one
million by 2010.[1] This reflects approximately 5% of the population. In Aboriginal and
Torres Strait Islander communities this percentage may be projected to be approximately
13%.[2] The onset of Type 2 diabetes has been reported to occur 9 to 12 years before
clinical diagnosis and thus complications of diabetes are often severe and when identified,
often the first indication of the presence of diabetes.[3] The early detection of undiagnosed
diabetes is a key intervention point in reducing the associated personal and community
burden. Both national and state governments acknowledge the disadvantage faced by rural
people in availing themselves of all aspects of diabetes management, from screening to
regular assessment, education and health care.[1]
Regular screening for complications of diabetes including vision, heart and foot
complications provides an opportunity to identify more of the people with unidentified
diabetes and provide early appropriate health care to these and people with eye, heart and
foot complications. Extrapolation from data obtained from eye health initiatives, indicates
that interventions that relieve or prevent complications associated with diabetes are highly
cost effective.[4]
Diabetic Retinopathy
Retinopathy is asymptomatic in the early stage. Up to 20% of people with non-insulin
dependent diabetes mellitus (NIDDM) have retinopathy at the time of diagnosis (Harris et al
92). Diabetes in indigenous Australians is 2-5 times the national average and as a group
Australian Aborigines suffer the fourth highest rate of NIDDM in the world.[5] Treatment to
prevent blindness is very effective provided the retinopathy is detected early.[6,7] However,
of people who know that they have diabetes, only 35% have regular eye checks in
Victoria.[4] This figure is somewhat higher in N.S.W. at 55%.[8] Several programs are
being discussed nationally to improve the screening percentages for diabetic retinopathy
with national figures aimed at 80%.[9] Working towards an increased awareness in the
community is one part of the solution, the other is to incorporate additional models for
diabetic retinopathy screening that complement currently existing eye-care service.[4,10]
Diabetic retinopathy (DR) could be significantly reduced by simplifying the procedure used
to diagnose the condition and ensuring that early eye examinations become routine for
diabetic patients, according to an advisory group convened by JDRF.[11] Rural screening
is difficult because of health care barriers such as geographical isolation, the cost of visits
to specialists and the lack of ophthalmologists available. [12-14]
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
6
Cardiovascular Disease
Cardiovascular disease, affecting the larger blood vessels is a major complication of
diabetes. People with diabetes are two to four times more likely to develop cardiovascular
disease and their prognosis is not as good. Diseases of the circulatory system such as
coronary heart disease and stroke were listed as the underlying cause of death in 55.7% of
deaths in 2000 where diabetes was an associated cause.[5] In addition some form of
nervous system damage that affects the function of the heart and blood vessels, occurs in
up to 60-70% of people with diabetes.[15] Regular screening and early recognition of
nervous system damage affecting cardiac function in people with diabetes allows better
treatment intervention and reduces the number of deaths associated with diabetes related
cardiovascular disease.[16]
Foot complications
In the Western world diabetic foot problems have been reported as the most common
complications of diabetes. Diabetic foot problems are associated with nerve damage
(diabetic neuropathy) and poor circulation (peripheral vascular disease) in the lower
limbs.[17] These factors increase the risk of foot ulcers, infection and lead ultimately to
lower extremity amputation. Among people with diabetes, 19.4% were found to be at risk
for foot ulcers and 2.1% reported absence of limbs. Peripheral neuropathy and peripheral
vascular disease were reported in 24.2% and 12.6% respectively. Regular monitoring of
the feet for early signs of diabetic neuropathy, peripheral vascular disease and foot
deformities reduces the risk of serious foot ulcers and amputation. An important adjunct to
reducing the percentage of amputations is to have appropriate assessment methods for
recognising vascular disease.[18, 19]
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
7
Quality of life and health care
Few studies have assessed the influence of social environment on health, but increasing
attention.[20] For effective health care public health workers involved in diabetes
prevention and control in all communities including ethnic and Aboriginal and Torres Strait
Islander communities. Health care professionals need to listen and engage with people
articulating their experiences of health and illness within the social, political, economic, as
well as biological context of their lives.[20] Communities within which public health workers
are now working are often not stable, connected and demographically as well as culturally
similar populations living within a traceable geographical location. This insight becomes
especially important for communities with increased incidence of diabetes and risk
behaviour. Assessing individuals in diverse communities effectively increases the quality of
life of individuals and the overall health of the community.
Impact of Early Intervention on Quality of Life for People with Diabetes
Complications
Quality of life is a term used in a number of disciplines, and definitions and
conceptualizations vary from utility of health states to life satisfaction and from possession
of socially desirable characteristics to positive affect. In order to address the quality of life
issues associated with the disproportionately high rates of diabetes and poor medical
service provision in rural and remote regions of Australia, alternative models of primary
health care have to be considered.[7] There is considerable variation in diabetes
management in different primary care settings even in the same hospital.[21] The main
difference was in consistent and appropriate screening for risk factors and complications in
people attending the clinics. Screening for diabetes has the potential to be an effective
intervention, especially if patients have intensive treatment of their newly diagnosed
diabetes. In a recent study the effectiveness of a home-based cardiac rehabilitation
program in improving health outcomes and rehabilitation access for special-needs patients
has shown that significant positive changes for measures of quality of life, knowledge of
angina, and exercise tolerance. Additionally, higher levels of participation and completion
were also noted.[22]
Outcomes research is used increasingly for assessing the health outcome benefits of new
therapeutic programs and interventions. Therefore measures of quality of life have to
consider gains in health outcomes and programs in diabetes.[23] To achieve uniform care
for all people with diabetes a on-stop assessment unit that makes the primary health care
team accessible to all, provides effective management of risks for diabetic patients by
advice, education, and therapeutic modification is the starting point to address quality of life
issues associated with diabetes.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
8
Assessment intervention strategies in rural/regional areas
Complications associated with diabetes remain often undetected for quite some time
especially in rural regions, but in a twist are often health problems that alert health care
providers to the presence of diabetes.[24] Government agencies as well as specialist
groups such as the Australian Diabetes Association advocate that routine screening of
persons at risk of diabetes allows earlier detection of the disease and better health
outcomes. Diabetes is a disease that is amenable to screening as the disease is common,
serious, and has a long asymptomatic phase. In addition acceptable tests exist for
identification of the disease and treatment must matter during the asymptomatic phase
(World Health Organisation Guidelines). The Australian Diabetes Association recommends
screening after 45 years of age and to be repeated every 3 years. However if hypertension,
cardiovascular disease, increased lipid levels, physical inactivity, gestational diabetes and
obesity are present, earlier and more frequent screening is required. This is also the case if
the person is of pacific island or indigenous origin. At a recent primary telemedicine
conference, Balsbaugh has reported that universal screening is feasible and cost effective,
it delays complications and younger patients have a longer time to benefit from early
identification.[25]
Barriers to effective screening and treatment
Barriers and strategies for general delivery of diabetes care in primary health care include
the lack of specialists in rural communities and often the cost of equipment required for
assessment.[1,26] Rural and remote areas experience relative deficits in supply of allied
health professionals in addition to relative deficits in the medical workforce. Despite
considerable policy focus on rural and regional health services geographic imbalances in
the primary health workforce supply levels persist. Further barriers are geographical
separation of health care providers, impaired communication and collaboration of
providers, impaired access to services and patient passivity and poor compliance. Any of
these will impact on activity levels and quality of life for people with complications
associated with diabetes.[27]
Barriers hindering optimal diabetes care delivery can be overcome by specific
strategies.[26] Ideally, the services are co-located and synchronised in a one-stop-shop.
Our mobile unit addresses several of the barriers such as providing co-located services, a
central data collection system that is online for access by health professionals that require
information for follow-up and by use of computer based assessment of possible vision and
heart anomalies requires less specialist input in routine screening.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
9
Strategies in assessment of complications of diabetes
Vision loss, cardiovascular disease and foot amputations are the most often occurring
outcomes of diabetes. Damage to the eye associated with diabetes (diabetic retinopathy) is
the commonest cause of blindness in the working age population in developed countries.
Yet 98% of people with vision loss can be treated effectively provided the pathology is
detected early. Cardiovascular complications associated with diabetes and on it’s own is
the commonest cause of death in the population.[24] Early detection of blood vessel
changes associated with retinopathy, cardiovascular disease and foot complications is
important for timely treatment to prevent or delay the occurrence of these complications
and improve the quality of life for individuals with diabetes.[13,28] Regular health screening
that includes eye, heart and foot assessment has the potential to reduce the high costs on
the health care system and reduces the disparity in health care between rural and urban
communities by providing timely feedback to those at risk.[29]
Eye Screening
Automating the assessment changes in the retina can be carried out using mathematical
techniques such as developed by our team and others.[30-32] These mathematical
techniques can be applied to the estimation of blood vessel diameter changes and quantify
the appearance of microaneurysms and haemorrhages as well as new vessel growth in the
advanced stages of diabetes. Identification of the number of microaneurysms is positively
correlated with diabetes. [33,34] Of interest has been the correlation between blood vessel
diameter changes in the eye that is not only associated with diabetes but is also an early
indicator for cardiovascular disease and stroke.[13]
Heart Assessment
Electrocardiology is still regarded as the most commonly used procedure for the
assessment of cardiac function and identification of heart disease, utilized by numerous
health care practitioners including community health nurses. We have investigated the
efficacy of 3-lead ECG assessment in community health with good outcomes suggesting a
cost benefit and improvement in health care.[35] We have also developed an ECG
classification protocol for community screening using 12-lead ECG that optimizes referrals
to general practice by reducing the number incorrectly referred through community
screening.[36]
ECG interpretation, although mostly automated is usually carried out by a specialist, be
that a cardiac nurse, general practitioner or cardiologist. The Charles Sturt Diabetes
Complications Screening Programme has investigated the possibility of primary health care
providers assessing heart function using an automated ECG assessment tool that differs to
the traditional method by evaluating the heart rate variability obtained using a 3-lead
recording. Our recording and interpretation tool adds two important features to heart
assessment. 1) it allows primary health care providers to record ECGs (placing 3-lead
ECGs is less complex compared to placing a 12-lead ECG and less invasive in community
health settings) and 2) identify asymptomatic changes in heart function associated with
diabetes.[37] Our method is based on observations that many cardiac anomalies, including
diabetic autonomic neuropathy, change the heart rate variability before any overt ECG
anomalies are detectable.[38,39] However, whereas cardiologists with current methods can
not pick up preclinical cardiac anomalies our method has the potential to do this.[40] In
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
10
addition relatively short 3-lead ECG recordings can be used in evidence based health care
and accountability for primary health care practice with lead II recordings showing a similar
efficacy in identifying at risk individuals as 12-lead ECG recordings.[41]
Foot Assessment
Regular monitoring of the feet for early signs of diabetic neuropathy, peripheral vascular
disease and foot deformities are essential.[5] Measurement of sensory impairment using
monofilament tests to identify peripheral neuropathy, ankle-brachial index to identify
peripheral vascular disease and observation of skin lesions and range of motion changes
at the ankles are direct and simple yet reduce the risk of serious foot ulcers and
amputation.[42] These measures provide an indicator for further assessment if required by
specialists using more sophisticated assessment procedures.[43] Charles Sturt University
has been assessing foot health as part of its Allied Health Clinic and this knowledge can be
incorporated into the mobile assessment unit. [18]
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
11
A one-stop mobile health check for diabetes
Incidence percentages stated above increase in the elderly, are higher in indigenous and
Torres Straight Islanders and in high-risk people such as those with a sibling having
diabetes or obesity. The impetus to establish a one-stop mobile health check for diabetes
stems from reported barriers to effective health care for people with diabetes, similar
studies undertaken in Australia for screening of eye complications and our own findings in
the Border region.[10] The UK National Service Framework for diabetes has also clearly
indicated that the modes of managing diabetes by offering regular easy-to-access diabetes
care and assessment improves health outcomes.[43] Anecdotes from participants at the
Albury-Wodonga diabetes complications screening has indicated that a one-stop screening
facility is preferred by the public that includes high risk individuals and people with
diabetes.[14] At the Border the diabetes complications screening group has carried out
cardiovascular complications screening at Tallangatta, a rural township and
Albury/Wodonga with good attendance. Considering cardiovascular complications in
diabetes account for 65% of all diabetic deaths, automated screening procedures
developed at Charles Sturt University and used at Tallangatta and Albury/Wodonga to
identify asymptomatic changes in heart function associated with heart rate variability
demonstrated the utility of these procedures. The results indicate that automated screening
for heart pathology has the potential to reduce cardiac morbidity through the early
identification of autonomic nervous system changes in people with diabetes and identifying
serious ECG anomalies.[37,39] Cree et al. (2002) have tested their automated procedures
for identification of asymptomatic changes in the eye associated with diabetic
retinopathy.[34] In collaboration with Leandro et al. (2003), the Charles Sturt University
diabetes complications assessment group have verified that these automated procedures
can be used for community screening.[29,44] Combining the automated eye and heart
assessment, with podiatric assessment of peripheral vascular and nervous system
dysfunction and on-the-spot biochemical checks for sugar, HbA1c and creatine levels
delivers a complete health care provision when combined with appropriate follow-up,
education to improve the quality of life of people with diabetes.[45,46]
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
12
References
1. Colagiuri S, Colagiuri R, Ward J. National Diabetes Strategy and Implementation Plan.
Canberra: Diabetes Australia, Paragon Printers; 1998.
2. Taylor HR. Eye health in Aboriginal and Torres Strait Islander Communities. Canberra:
Commonwealth Department of Health and Aged Care; 1997.
3. Harris MI, Klein R, Welborn TA, Knuiman MW. Onset of IDDM occurs at least 4-7 yr
before clinical diagnosis. Diabetes Care 1992;15:815-819.
4. Lee SJ, McCarty CA, Taylor HR, Keeffe JE. Costs of mobile screening for diabetic
retinopathy: a practical framework for rural populations. Australian Journal of Rural
Health 2001;9:186-192.
5. AIHW. Diabetes: Australian facts. Canberra: AIHW; 2002. Report No.: Cat. No. CVD
20, Diabetes Series No 3.
6. Icks A, Trautner C, Haastert B, Berger M, Giani G. Blindness due to diabetes:
population-based age- and sex-specific incidence rates. Diabetic Medicine
1997;14:571-575.
7. Lee SJ, Sicari C, Harper CA, Taylor HR, Keeffe JE. Program for the early detection of
diabetic retinopathy: A two-year follow-up. Clinical and Experimental Ophthalmology
2001; 29:12-25.
8. PHD. Report on the 1997 and 1998 NSW Health Surveys. Accessed 1 Sept 2003, NSW
Health Department, Sydney. http://www.health.nsw.gov.au/publichealth/nswhs/diab/gm_diab_d9_cat.htm
9. NHMRC. National Health and Medical Resarch Council. National evidence based
guidelines for the management of type 2 diabetes mellitus. Sydney: Australian Centre
for Diabetes Strategies; 2001.
10. Taylor HR, Keeffe JE. World blindness: a 21st century perspective. British Journal of
Ophthalmology 2001;85:261-266.
11. JDRF. Research Breakthroughs. Diabeteic Retinopathy Group makes
recommendations on diabetic retinopathy. New York: Juvenile diabetic Research
Foundation; 2000.
12. Ariyasu R, Lee P, Linton K, LaBree L, Azen S, Siu A. Sensitivity, specificity and
predictive values of screening tests for eye conditions in a clinic-based population.
Ophthalmology 1996;103:1751-1760.
13. Wong TY, Klein R, Sharrett AR, Schmidt MI, Pankow JS, Couper DJ, et al. Retinal
Arteriolar Narrowing and Risk of Diabetes Mellitus in Middle-aged Persons. Journal of
the American Medical Association 2002;287(19):2528-2533.
14. Jelinek HF, Tinley PsNRAHPC, Sydney, (abstract accepted). A rural diabetes clinic:
Potential in Albury-Wodonga. In: 1st Rural Allied Health Professional Conference;
Sydney; 2003. p. in print.
15. Rathmann W, Ziegler D, Jahnke M, Haastert B, Gries FA. Mortality in diabetic patients
with cardiovascular autonomic neuropathy. Diabetic Medicine 1993;10(9):820-824.
16. Pagani M. Heart rate variability and autonomic diabetic neuropathy. Diabetes,
Nutrition and Metabolism 2000;13(6):341-346.
17. Campbell LV, Graham AR, Kidd RM, Molloy HF, O'Rourke SR, Colagiuri R. The lower
limb in people with diabetes. Position statement of the Australian Diabetes Society.
Medical Journal of Australia 2000;173:369-371.
18. Austin M, Jelinek HF, Cole K. Normative data in podiatric practice for detecting
abnormal ankle/toe-brachial index. In: General Practice and Primary Health Care
Research Conference; Canberra; 2003. p. 101.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
13
19. Tinley P, Taranto M. Analysis of the relationship between lower limb motion and foot
ulceration in people with diabetes. Australasian Journal of Podiatric Medicine
2000;34(2):67.
20. Liburd LC, Vinicor F. Rethinking diabetes prevention and control in racial and ethnic
communities. Journal of Public Health Management and Practice
2003;November(Suppl):S74-S79.
21. Suwattee P, Lynch JC, Pendergrass ML. Quality of care for diabetes patients in a
large urban hospital. Diabetes Care 2003;26(3):563-568.
22. Warrington D, Cholowski K, Peters D. Effectiveness of home-based cardiac
rehabilitation for special needs patients. Journal of Advanced Nursing 2003;41(2):121129.
23. Testa MA, Simonson DC, Turner RR. Valuing quality of life and improvements in
glycemic control in people with Type 2 diabetes. Diabetes Care
1998;21(3(Suppl)):44C-52C.
24. Mathers C, Vos T, Stevenson C. The burden of disease and injury in Australia.
Canberra: AIHW; 1999. Report No.: PHE 17.
25. Balsbaugh TA. Diabetes Care 2001: Update and clinical controversies. In:
Telemedicine Conference; 2001.
26. Heazlewood V, Smallhorn R, Geraghty M, Buckmaster N. Strategies for overcoming
the barriers in delivery of diabetes care in general practice. In: General Practice and
Primary Health Care Research Conference; Canberra; 2003. p. 145.
27. Piette JD. Perceived access problems among patients with diabetes in two public
systems of care. Journal of General Internal Medicine 2000;15(11):797-804.
28. Wang JJ, Mitchell P, Sherry LM, Smith W, Wong TY, Klein R, et al. Generalized retinal
arteriolar narrowing predicts 5-year cardiovascular and cerebro-vascular mortality:
findings from the Blue Mountains Eye Study. Investigative Ophthalmology & Visual
Science 2002:43.
29. McQuellin CP, Jelinek HF, Joss G. Characterisation of fluorescein angiograms of
retinal fundus using mathematical morphology: a pilot study. In: 5th International
Conference on Ophthalmic Photography.; Adelaide; 2002. p. 83.
30. Jelinek HF, Cesar Jr. RM, Leandro JJG. Automated Detection of Proliferative Diabetic
Retinopathy. In: Australian Diabetes Association Conference; Melbourne; 2003. p.
167-168.
31. Landini G, Misson GP, Murray PI. Fractal analysis of the normal human retinal
fluorescein angiogram. Current Eye Research 1993;12(1):23-27.
32. Sherry LM, Wang JJ, Rochtchina E, Wong TY, Klein R, Hubbard LD, et al. The
reliability of computer-assisted retinal vessel measurement in a population. Clinical &
Experimental Ophthalmology 2002;30(3):179-182.
33. Jelinek HF, Cornforth D, Cree M, Cesar J, R.M., Leandro JJG, Soares JVB, et al.
Automated characterisation of diabetic retinopathy using mathematical morphology: a
pilot study for community health. In: 2nd Annual NSW Primary Health Care Research
and Evaluation Conference; 2003. p. 48.
34. Cree MJ, Olson JA, McHardy K, Sharp P, Forrester J. A fully automated comparative
microaneurysm digital detection system. Eye 1997;11:622-628.
35. Jelinek HF, Warner P, King S, deJong B. Opportunistic screening for cardiovascular
problems in community health. Journal of Cardiovascular Nursing 2006;21(3):217222.
36. Jelinek HF, deJong B, Warner P, Wang L. Efficacy of a rural university-based
cardiovascular disease screening clinic using 12-lead ECG: Early implication of
treatment or prevention. Internal Medicine Journal 2006;submitted.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
14
37. Warner P, Jelinek HF, Dulfer A, Teak J. Lead II ECG Assessment as Part of a
Diabetes Screening Program. In: Australian Diabetes Association Conference;
Melbourne; 2003. p. 157.
38. Ewing DJ, Neilson JMM, Shapiro CM, Stewart JA, Reid W. Twenty four hour heart rate
variability: effects of posture, sleep, and time of day in healthy controls and
comparison with bedside tests of autonomic function in diabetic patients. British Heart
Journal 1991;65:239-244.
39. Flynn AC, Jelinek HF, Smith MC. Automated screening for cardiac dysfunction in
diabetes using short ECG recordings and non-linear analysis. In: General Practice and
Primary Health Care Research Conference; Canberra; 2003. p. 121.
40. Mäkikallio TH, Huikuri H, Hintze U, Videbæk J, Mitrani RD, Castellanos A, et al.
Fractal analysis and time- and frequency-domain measures of heart rate variability as
predictors of mortality in patients with heart failure. The American Journal of
Cardiology 2001;87:178-182.
41. Jelinek HF, Warner P, Cornforth D, Dulfer A. ECG assessment by community nurses
in rural and remote regions: 12-lead versus 3-lead ECG assessment. In: 2nd Annual
NSW Primary Health Care Research and Evaluation Conference; Sydney; 2003. p. 50.
42. Clingan T, McGill M. Foot care for diabetes: a scarce resource. Diabetes
Management Journal 2003;6(October):12.
43. Mani R, Krentz AJ, Shearmann CP. Diabetic foot amputation: the need for an
objective assessment tool. Wounds 2003;15(7):241-245.
44. Cesar J, R. M., Jelinek HF. Segmentation of retinal fundus vasculature in
nonmydriatic camera images using wavelets. In: Laxminarayan S, editor. Angiography
and plaque imaging. London: CRC Press; 2003. p. 193-224.
45. Ludwig-Beymer P, Arndt D. Using baseline data to improve care of patient with Type II
diabetes melllitus. Journal of Nursing Care Quality 1999;13(6):1-10.
46. Delaney BC, Hyde CJ, McManus RJ, Wilson S, Fitzmaurice DA, Jowett S, et al.
Systematic review of near patient test evaluations in primary care. BMJ
1999;319(7213):824-827.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
15
Risk
Management
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
Plan
16
Form 36:
Risk Management Plan
Version: 1.1
May 2006
Next Review:
May 2008
Diabetes Complications Screening and Research
The aim of this Risk Management Plan is to identify major risks in the Diabetes Complications
Screening and Research and to analyse and manage them effectively.
This plan is intended to supplement relevant legislation, regulations and guidelines. Students
and researchers participating in the screening and research must maintain good research
practice, have knowledge of human research ethics (including privacy) and intellectual property
management, have an understanding of OH&S and be appropriately trained in all procedures
they undertake.
This document must be approved by the Head of School before any work is undertaken.
Attachments are attached and indicated in the appropriate place.
1. Project Title: Diabetes complications screening and research
2. Project Type: Staff Research, Postgraduate, Clinical Placement and Tutorial
3. Outline of Proposed Procedures
Note: SOPs attached for all above procedures
 Blood collection by finger prick - assessment of random or fasting blood glucose
 Blood collection by venepuncture – range of biochemical tests
 Foot sensation tests – assessment of nervous system function
 Blood Pressure (BP) Recordings –ankle brachial index (ABI), and lying to standing BP
 Calculation of BMI - Height, weight & waist circumference measurements
 Eye test – Photograph of the retina of the eye using a non-mydriatic camera
 ECG - normal 12 lead ECG recording
 ECG - 3 Lead ECG recording (2o minute) for heart rate variability
 Autonomic nervous system (ANS) function tests – controlled breathing, handgrip, BP
monitoring, valsalva manoeuvre
4. Participants
Coordinator: Dr H Jelinek
Supervisors: Herbert Jelinek, Paul Tinley, Paul Warner
Operators: Herbert Jelinek, Paul Tinley, Harriet Farquhar, Paul Warner, Bev deJong,
Cherryl Kolbe, Uba Nwose
Others (outside School): 2nd / 3rd year nursing students and 4th year podiatry students
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
17
doc(190706).doc
5. Location: Rooms 119 and 126, The Cedar building, Olive Street, Albury NSW 2640
6. Expected Duration: From 26 July 2006 ongoing fortnightly screening
7. Identified Risks
Safety & Environment
 Hazardous substances
 Infectious agents
 Portable electrical equipment, power boards & extension leads
 Biological waste
Occupational Health
 Stress
Accident conditions
 Slips, trips and falls
 Participant fainting
 Participant experiencing a hypoglycaemic event
 Participant experiencing a cardiac event
 Patient experiencing an epileptic fit
 Failure to identify & follow up an abnormal test result
 Failure to monitor participants effectively
 Failure to oversee emergency procedures
Values, ethics and reputation
 Serious breach of protocol or ethics committee requirements
 Serious breach of confidentiality
Data quality and management
 Fraud in collection of data
 Serious errors in analysis of data
 Loss of data due to inadequate
 Data back-up procedures
Business Continuity
Finance
 Insurance
Compliance
Student experience
Other

S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
18
8. Equipment Required – See attached SOPs

Non-mydriatic camera

ECG recording equipment

Standard blood collection equipment
 All other equipment as standard use in Allied Health Clinic.
9. Personnel Data (list ALL persons involved in the project)
Name
Title
Training and Experience in this type of Operation
use
of non-mydriatic camera, ECG, foot sensation
Herbert Jelinek
Dr
tests, ABI, ANS function tests, BP recordings, BMI
Paul Tinley
Dr
ABI, foot sensation tests
Paul Warner
Mr
Bev deJong
Ms
Cherryl Kolbe
Ms
Students as listed in
attachment
ECG, venipuncture, finger prick
Finger prick, use of non-mydriatic camera, ECG, foot
sensation tests, ABI, ANS function tests, BP
Venipuncture,
finger prick, use of non-mydriatic
recordings, BMI
camera, ECG, foot sensation tests, ABI, ANS function
tests, BP recordings, BMI
Note:
 All CSU staff listed above have been appropriately trained in these procedures as
outlined in the attached training register.
 See table 1 for risk assessments
10. Conclusions of the risk assessment
All identified risks require strategies to reduce the likelihood of occurrence. It is not
practical to eliminate any of the risks by disallowing the activities.
The risk assessment and risk management plan is shown in Table 1.
11. Risk management
Any risks associated with the Diabetes Complications Screening and Research can be
managed by setting a standard for research activities and by developing good research
practice by all researchers and ensuring researchers are suitably trained in all procedures.
12. Monitoring and review
The Risk Management Plan for the Diabetes Complications Screening and Research will
be distributed to all researchers involved.
Responsibility for monitoring and review rests with the Coordinator Dr H. Jelinek.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
19
13. Signed (ALL persons involved in the project)
Names:
Signatures:
Herbert Jelinek
Paul Tinley
Paul Warner
Bev deJong
Cherryl Kolbe
14. Supervisor’s Approval and Comments ...............................................................
Name:
......................................................................................................................................
......................................................................................................................................
Signed ................................................................................. Date .........................
15. Head of School's Approval and Comments
......................................................................................................................................
......................................................................................................................................
......................................................................................................................................
Signed ................................................................................. Date .........................
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
20
Identification of risks
The risks identified in this document are those recognized to date, however, further risks may be identified in
the future and will be added to later versions of this document.
The potential risks identified relate to:
 Safety & Environment
 Occupational Health
 Accident conditions
o Failure to monitor participants effectively or oversee emergency procedures leading to
serious injury or death of a participant
 Values, ethics and reputation
o Serious breach of protocol or ethics committee requirements
o Serious breach of confidentiality
o Human ethics
 Data quality and management
o Fraud in collection of data
o Serious errors in analysis of data
o Loss of data due to inadequate back-up procedures
 Business Continuity
 Finance
o Insurance
 Compliance
 Student experience
Risk analysis
This risk analysis was carried out according to the AS/NZS 4360:2004 Risk Management and Charles Sturt
University’s risk management Strategic Framework 2005.
The likelihood of occurrence of each event was rated on a scale A-E.
Score
A
B
C
D
E
Descriptor
Almost certain
Likely
Possible
Unlikely
Rare
Likelihood Rating
Could happen at any time
Could happen sometime
Could happen, but very rarely
Could happen, but probably never will
Could happen, but only in exceptional circumstances
The consequences were also ranked in degree of severity on a scale of 1-5.
Ranking
1
Degree of
Severity
Insignificant
2
Minor
3
Moderate
Detail Description
















Complaints that can be dealt with routinely
Financial loss that comes within the relevant financial delegation level
Political enquiries resolved by routine management procedures
The consequences are dealt with by routine operations
Minor health impairments to patients and researchers
Threaten the efficiency or effectiveness of some aspects of the School
Financial loss that would impact on the research group
Complaints that can be dealt with internally
Unexpected/unplanned health impairments to patients and/or researchers
Be serious for the Program/School either financially or politically
Result in need for study to be repeated at considerable cost and effort
Result in irreversible loss of essential data; may require considerable time
and expenditure to reconstruct database
Would not threaten survival of the program, but could be subject to
significant review or changed way of operating
Result in negation of the study data with results being unreportable and
unpublishable
Result in necessity to notify ethics committee
Adverse media coverage
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
21
4


Major





5

Severe



Lead to significant legal action against researchers and CSU
Unexpected/unplanned loss of life, or permanent impairment of quality of life
on a single scale
Result in loss of >5% of research revenue
Result in serious adverse publicity for the School and CSU and significant
loss of reputation
Required retraction of published article/s
Lead to serious legal action against researchers and CSU
Result in research progressing without ethics committee approval
(researchers lose protection of institution and insurers)
Unexpected/unplanned loss of life, or permanent impairment of quality of life
on a multiple scale
Screening program terminated
Result in serious adverse publicity for the School and CSU and significant
loss of reputation
Result in a parliamentary enquiry and loss of government confidence
The overall level of risk was determined by combining the consequence and likelihood ratings
Consequence
Likelihood
A
B
C
D
E
Almost
certain
Likely
Possible
Unlikely
Rare
1
Insignificant
L
2
Minor
M
3
Moderate
H
4
Major
E
5
Severe
E
L
L
L
L
M
L
L
L
H
M
M
L
E
H
H
M
E
E
H
H
(Adapted from AS/NZS 4360:2004, Risk Management. Under the CSU risk management approach the
colour of the risk grade will be contingent on likelihood, consequence and risk grade calibrations that are
agreed with the activity sponsors.)
Key:
L = low risk
M = Moderate
H = High risk
E = Extreme risk
managed by routine procedures. No major concern
specified responsibilities of Coordinator Dr H. Jelinek
attention/monitoring by Coordinator Dr H. Jelinek
immediate action required
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
22
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
23
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
24
Table 1 Risk assessment and risk management plan.
Likely circumstances
Assessment of risk
Major consequences if risk not managed
Risk management strategies
Likelihood
Consequence
Risk
001/06
Fraud in collection of data
Identified risks: Researcher responsible for interviewing patient invents data rather than following protocol
Researcher alters data to make the results more likely to fit his/her preconceived idea of what results should show
Where researcher:
 collects data without close supervision
 have not been appropriately trained and
briefed
 operate without their data being checked
 operate without proper supervision
Occasionally
 Study data may be worthless resulting in
unreportable and unpublishable results
 Published article may require retraction
 Screening may need to be repeated at
considerable cost and effort
 Ethics committee needs to be notified





Develop a strong culture emphasising care and accuracy in data
collection
The Coordinator to ensure all researchers are adequately trained
in research methods/ethics.
Research protocols are required to have adequate quality control
procedures which are likely to detect falsified data. The
Coordinator to ensure that quality control measures are reviewed.
All new researchers will be adequately briefed on the need for
accuracy in data collection.
Standard operating procedures in place for most key data
collection procedures, including quality control procedures
002/06
Serious errors in analysis of data
Identified risks: Serious error made in the analysis of a data set leading to the need to retract a published article or correct a report.
Researcher may fraudulently alter results to fit preconceived hypothesis or to increase the likelihood of publication of the results. Colleagues involved in current and previous research could have their reputations
tarnished.
 Serious errors are more likely if data
analysis is undertaken by inexperienced &
unsupervised persons.
 Inappropriate application of computer data
analysis by inexperienced people

Occasionally
through
inexperience
or inadequate
supervision

Study data may be worthless resulting
in unreportable and unpublishable
results
Published article may require retraction
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc


Ensure that all key research data is analysed by two
independent persons, with a statistician involved
All PhD students should have key results checked by a
statistician
25
003/06
Loss of data due to inadequate back-up procedures
Identified risks: A systematic process with frequent inspection is required for updating and regular backing up of previous copies of the database.
Database kept in a secure location.




When databases are established and
maintained by researchers without the
close support of an experienced
programmer or database manager.
When databases are constantly being
updated, especially if more than one person
is involved in data entry or if different
people are involved in data entry and data
editing.
At the data checking/editing stage it may be
easy to lose track of which is the most
current version of the database.
A substantial risk of data loss due to theft,
malicious destruction or fire may occur if all
copies of a database are kept in the one
location or on the same computer


Almost
certain,
unless
specific
precautions
are taken

Irretrievable loss of essential data
Expenditure of considerable expense
and time in reconstructing the
database
Other funding implications (eg. cost of
repeating research)






Develop detailed standard operating procedures relating to data
management
Provide training in data management procedures via short course
and/or postgraduate programs
Coordinator to review data management procedures
Daily back up of data files
provision of training in data management procedures via short
course and postgraduate programs
review of data management procedures as an essential
component of reviews conducted by the research auditor
004/06
Serious breach of protocol or ethics committee requirements
All research involving humans must be endorsed by Charles Sturt University’s human ethics committee. The committee requires all study participants to be provided with an approved information sheet and to sign an
informed consent sheet that indicates their readiness to participate in the project. These forms must be readily available for auditing purposes and should a participant claim that they had not been adequately informed of
the risks and benefits of participation. Serious adverse events affecting any study participant, and considered reasonably likely to have resulted from study participation, must be notified urgently to the human ethics
committee.


Where the Coordinator becomes too busy
to provide adequate supervision of the
research programs.
Lack of knowledge of the ethics
committee’s role in the regulation and
monitoring of the research program.

Likely

Research may not take place without
ethics committee approval.
Adverse events affecting a participant
could lead to serious adverse publicity.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc


Insist on adequate training of researchers
Coordinator to monitor compliance with ALL human ethics
committee requirements
26
005/06
Serious breach of confidentiality
The human ethics committee approves the collection of personal health-related data for research purposes only if they are assured that the data will be maintained under strict conditions that protect the confidentiality of the
participants.
Privacy requirements to be observed by researchers have become more explicit with the adoption of new legislation that must be observed by all those involved in the collection of personal data. Breaches of these
requirements may result in criminal penalties.
Components of the procedures required for privacy protection include:

restriction of access to personal data to a small number of individuals with a need for access

training of researchers at all levels in the issues related to data confidentiality

provision of secure storage of confidential data which includes restricted access to areas where such data is stored, separation of identifying data from the other data elements, secure password access to data in
computers and development of a specific protocol for destruction of identifying data when no further need exists to retain this information.

requirement for all staff involved in data collection or processing to sign a confidentiality declaration at yearly intervals



where there has been little attempt to create
a culture of confidentiality and reinforce it.
where new researchers who have not been
adequately educated about the rationale for
confidential data handling are given
responsibilities in this area.
where a research staff member handles data
from an individual known to the researcher
and is tempted to mention this outside the
university

Likely

Could result in serious
adverse publicity
May lead to legal action
from participants whose
privacy has been breached



Require all researchers to sign an annual confidentiality agreement
Coordinator to emphasise privacy requirements to researchers
Coordinator to create a culture of confidentiality
006/06
Failure to identify and follow up an abnormal test results
Identified risk: Many research studies involve the measurement of physiological variables (eg blood pressure). When large numbers of individuals are tested, there is a strong possibility of finding abnormalities of clinical
significance that may not be known to the individual or his/her medical practitioner. In some instances, recognition of the abnormality may allow effective treatment to be introduced.

The primary risk setting is where screening
tests are being done on large numbers of
individuals either as part of eligibility
screening for a research study or as part of
an epidemiological study


Failure to include efficient
procedures to pass on
important clinical
information may mean that
a potentially curable illness
is not detected
May lead to significant
legal action for negligence


All studies involving physiological measurement or laboratory testing must
include specific procedures to review all abnormal results.
These procedures must be documented in the protocol and procedure manual
and adherence monitored by the Coordinator.
007/06
Provision of appropriate insurance cover for CSU students undertaking course related work experience with CSU
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc
27

S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc
28
008/06
Failure to monitor participants effectively or oversee emergency procedures leading to serious injury or death of a participant
Identified risk: Some clinical research projects, particularly those conducted on patients with conditions such as hypertension or cardiovascular disease, may require special attention to monitoring and the availability of
emergency care. The risk of medical complications resulting from screening tests may be sufficiently high as to mandate the availability of urgent medical assessment and/or emergency care.
If such emergency care was not immediately available and, as a result, a study participant died or developed serious complications, serious repercussions would follow for both the investigator and the institution.

The risk is greater when studies are
supervised by inexperienced staff and when
senior clinical investigators are unavailable or
not able to be contacted.
occasionally
May lead to:

death or serious injury to a
participant

serious legal action
against researchers

serious adverse publicity


Ensure that detailed standard operating procedures are developed
Adherence to standard operating procedures to be reviewed by Coordinator


All persons performing blood pressure measurements will be appropriately
trained and the training recorded.
009/06
Blood Pressure Recording using a Digital Blood Pressure Monitor
Identified risks: Over-inflation of the cuff may cause minor discomfort

When inappropriately sized cuff is used
Slight bruising may occur
010/06
Electrocardiogram (ECG)
Identified risks: There are no known risks associated with an ECG, however, participants may have a sensitivity to the electrode adhesive or alcohol skin preparation swab.
011/06
Venipuncture
Identified risks: Patient experiencing nausea, light-headedness, dizziness, fainting. Needle stick injury.
Faint 
If the participant is nervous or the room is

Stick warm

If venipuncturist is inexperienced or not
taking due care

Participant may injure
themselves while fainting if
not supported
Needle stick injury to
either participant or
venipuncturist


Participants will be asked if they have any skin sensitivities
All persons performing ECGs will be appropriately trained and the training
recorded.



Maintain room at a comfortable temperature
Have the participant lying down while taking the blood
Inform the participant of the possibility of discomfort. Ask them if they have
previously fainted.
Have available the following first aid measures:
first aid kit
first aid officer
emergency phone numbers near the most accessible phone
All persons performing venipuncture will be appropriately trained and the
training and competency recorded.


012/06
Finger prick
Identified risks: nil
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc
29
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc
30
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete doc(190706).doc
31
Standard Operating Procedures (SOP)
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
32
STANDARD OPERATING
PROCEDURE
Venipuncture Technique Using the Multisample Vacutainer System
SOP No: .................................... Version: 1.0 ................................. Date: 3 April 2006
Dept/Div/School:
School of Community Health
Supervisor/Manager:
Cherryl Kolbe
Other Contacts:
Bev deJong
RISKS/HAZARDS:
Venipuncture is a procedure where there is this potential for direct contact
between the skin (usually finger or thumb) of the blood collector and a
sharp surgical instrument such as a needle.
It is essential that realistic assessments are made of the likelihood and
severity of any injuries arising from venipuncture. Both physical and
psychological risks must be assessed.
a) Ethical issues
 Subjects should not feel they have been abused as a result of
venipuncture. This could include excessive pain or discomfort and
embarrassment or humiliation.
b) Physical Risks
 Patient experiencing nausea, light-headedness, dizziness,
fainting
 Needle stick injury
PROTECTIVE &
EMERGENCY
EQUIPMENT




CONTROL MEASURES





Disposable gloves
Gown & protective eyewear if appropriate
There must be a First Aid / CPR trained person available in case of an
emergency.
Emergency procedures must be in place – refer to Physiology
Laboratory “Guidelines for Medical Emergencies”
Inform the patient of the possibility of discomfort or embarrassment.
Have the patient lying down with the head slightly raised on a pillow.
Have available the following first aid measures:
 first aid kit
 first aid officer
 emergency phone numbers near the most accessible phone
Only suitably qualified and experienced staff may perform
venipuncture
Those performing venipuncture must comply with the following
Physiology Laboratory Guidelines:
 Venipuncture
 Medical Emergencies
 Infection Control
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
33
EQUIPMENT...................













JOB STEPS
Clinically clean table outside laboratory area
Tourniquet
Appropriate vacutainer tubes (per person), labelled.
 2 x 7ml EDTA tubes (purple top)
 1 x 10ml tube with 100L preservative heparin
 1 x 7ml plain tube (orange top)
5ml plain tubes for Hcy (one per person)
21g multiple sample needle or 21g winged infusion device
Plastic sleeve to hold specimen tubes
Isopropyl alcohol (70%) swabs
Cotton wool balls
Adhesive plaster or bandaids
Disposable gloves
Laboratory coat
Sharps container
Eye protection if deemed necessary by risk assessment
 Ensure all equipment is within easy reach and accessible.
 Select tube or tubes appropriate for samples desired. (see note at
end). Label the tubes.
 Tubes that contain additives should be gently tapped to dislodge any
additive, which may be trapped around the stopper.
 Open needle package, but do not remove needle shield. Thread
needle onto holder.
 Select site for venipuncture.
 Put on the disposable gloves
 Apply tourniquet. Prepare venipuncture site with an appropriate
antiseptic. (isopropyl alcohol swab)
 DO NOT PALPATATE VENIPUNCTURE SITE AFTER CLEANSING.
 Place patient's arm in a downward position.
 Remove needle shield.
 Insert the needle into the vein ensuring the bevel of the needle is
uppermost.
 Push tube onto holder, puncturing the diaphragm of the stopper.
 If no blood flows into tube or ceases to flow before an adequate
sample is collected, the following steps are suggested to complete
satisfactory collection:
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
34

Change the position of the needle. Move it forward (it may not
be in the lumen)

or move it backward (it may have penetrated too far)

Adjust the angle (the bevel may be against the vein wall)
 When first tube is full and blood flow ceases, remove it from the
holder.
 While each successive tube is filling, invert the previous tube
containing additives 8-10 times. DO NOT SHAKE. Vigorous mixing
can cause haemolysis.
 Release the tourniquet after inserting the last tube. When the last tube
has been removed (gold to tube), gently cover the needle tip with a
cotton wool ball and remove the needle from the vein. Ask the patient
to apply pressure to the puncture site until bleeding stops.
 After the venipuncture, dispose of the holder and the needle into an
approved sharps container.
 Transfer the contents of the gold top vacutainer tube to the tube
containing the preservative free heparin and invert gently to mix.
 Check the patient’s arm and cover the site with a bandaid. Do not
allow the patient to leave until the bleeding has stopped.
 If breakage of a tube containing a collected sample should occur,
avoid all contact with the exposed skin and follow proper procedures
for the clean up and disposal of infectious waste.
WHEN YOU FINISH
 Discard gloves and wash hands.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
35
Sample tubes for collection
Tube
Test
Volume of whole blood
Requirement
Storage
EDTA
Homocysteine
8ml
Plasma
-800C
EDTA
MetHb, viscosity
8ml
Whole blood
Room temp
Preservative
free Heparin
GSH, MDA
D-dimer,
cholesterol profile
RBC hemolysate
-40C
Plasma
-200C
4ml
2 x 7ml EDTA tubes (purple top)
1 x 7ml plain tube (orange top)
1 x 10ml tube with 100L preservative free heparin
Collect the two EDTA tubes first and the plain tube last. As soon as the plain tube is collected transfer the
blood to the tube containing the preservative free heparin. Invert well to mix. Place this tube and a 7ml
EDTA tube in a rack and keep on ice until collected by biochemist.
Centrifuge one 7ml EDTA tube. Collect plasma, label and store at -800C.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
36
Standard Operating Procedure
(SOP)
Blood Collection by Finger Prick
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
March 2001
Ext. 16995
Ext. 16995
HAZARDS:

Lancet stick
PROTECTIVE
EQUIPMENT &


Disposable gloves
Face mask and/or protective eye if required
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU START


Wash hands in warm soapy water
Rinse well and dry completely






If using an alcohol wipe, let the finger dry completely before
testing
Warming fingers can increase blood flow
Prepare the lancet device according to the manufacturers
instructions
Put on disposable gloves
Prick the finger to obtain the blood sample
Cover the wound with a cotton ball held in place by the patient
Dispose of the lancet in an approved sharps container
Remove the cotton ball and apply a spot band



Remove gloves
Wash hands in warm soapy water
Rinse well and dry completely
NEVER.........................
JOB STEPS


WHEN YOU FINISH
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
37
Standard Operating Procedure
(SOP)
Manual Blood Pressure Measurement
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
May 2006
Ext. 16995
Ext. 16995
HAZARDS:

Over-inflation of the cuff may cause minor discomfort
PROTECTIVE
EQUIPMENT &

nil
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU START



Wash hands in warm soapy water
Rinse well and dry completely
Have the participant assume a relaxed supine position for 5
minutes prior to taking a resting BP measurement. The arm
should be at the level of the heart with the palm up for
Brachial measurement , legs should be in a near horizontal
position knees slightly flexed for Ankle measurement
Observe and question participant for contraindications for
taking BP (i.e. lymphedema) and signs and symptoms of
BP alterations: high (headache, flushing of face,
nosebleed, fatigue in older adults) and low BP (dizziness;
mental confusion; restlessness; pale, dusky or cyanotic
skin; cool, mottled skin over extremities)

NEVER.........................
JOB STEPS








Explain the procedure to the participant
Select appropriately sized cuff
Expose the extremity fully by removing any constrictive
clothing
Palpate the brachial artery (arm) or posterior tibial (leg)
Position the cuff 2.5cm above the site of pulsation
Apply the cuff above the artery by centring the arrows
marked on cuff over the artery
Wrap the fully deflated cuff evenly and snugly around the
extremity
If the participant’s baseline BP is unknown, estimate the
systolic pressure by palpating the artery distal to the cuff
with the fingertips of one hand while inflating the cuff
rapidly to a pressure 20mmHg above the point at which
pulse disappears. Slowly deflate the cuff and note the
point when the pulse reappears. Deflate cuff fully and wait
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
38

30 sec.
Place the stethoscope earpieces in ears and ensure
sounds are clear. Place the bell or diaphragm chest-piece
of the stethoscope over the artery without touching any
clothing.
Close the valve and rapidly inflate to 20mmHg above the
systolic pressure
Slowly release pressure bulb valve and note the point when
the first clear sound is heard.
Continue to deflate the cuff, noting the point at which the
sound disappears
Release the remaining air quickly


Record your results
Wash hands




WHEN YOU FINISH
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
39
Standard Operating Procedure
(SOP)
Ankle Brachial Index (ABI)
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
HAZARDS:

Stepping down from plinth
PROTECTIVE
EQUIPMENT &

nil
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU START
June 2006
Ext. 16995
Ext. 16858
Wash hands in warm soapy water
Rinse well and dry completely
NEVER.........................
JOB STEPS


Doppler
Technique



Automated digital
Blood Pressure

Measure highest systolic reading in both arms
Record first Doppler sound as cuff is deflated
Record at the radial pulse
Measure systolic readings in both legs
Cuff applied to calf
Record first Doppler sound as cuff is deflated
Use Doppler ultrasound device
Record dorsalis pedis pressure
Record posterior tibial pressure
Use PT for each leg when calculating ABI.
Apply digital cuff of correct size and record brachial
BP for each arm
Apply cuff to ankle (leg slightly flexed at knee)
ensuring that the cuff lies firmly and flat against the
skin, ensure tubing is not bent and that the arrow is
aligned with the posterior tibial artery. Record BP
for each leg
A cushion may be used to support the lower leg
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
40
WHEN YOU FINISH
Calculations
 Ratio of each ankle to brachial systolic blood
pressure
 Divide each ankle systolic pressure by
corresponding systolic brachial pressure
Interpretation
Ankle-Brachial ratio >0.95: Normal
Ankle-Brachial ratio <0.95: Peripheral Vascular Disease
Ankle-Brachial ratio <0.6: Intermittent Claudication
Ankle-Brachial ratio <0.5: Multi-level disease
Ankle-Brachial ratio <0.26: Resting ischemic pain
Ankle-Brachial ratio <0.2: Gangrenous extremity
False Negative Test: Diabetes Mellitus
Vessels in diabetics are poorly compressible
Results in falsely elevated ankle pressure
For elevated ankle SBP indicating calcification use the
ruler adjustment and measure again.
Management
Segmental Arterial Pressure indicated for ratio < 0.9
Consider angiography or Magnetic resonance angiography
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
41
Standard Operating Procedure
(SOP)
Body Mass Index (BMI)
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
May 2006
Ext. 16995
Ext. 16995
A measure of body weight relative to height. BMI can be used to determine if people are at a healthy weight,
overweight, or obese.
HAZARDS:
 nil
PROTECTIVE
EQUIPMENT &

nil
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU START


Wash hands in warm soapy water
Rinse well and dry completely


Greet the participant & explain what you are going to do
Ask the participant to remove their shoes and any heavy items
from their pockets
Record weight in kg using bathroom scales
Record height in meters using the stature meter
Record waist circumference in cms - do not approach the
participant from the front
NEVER.........................
JOB STEPS



WHEN YOU FINISH

Calculate Body Mass Index (BMI) as follows:
Weight (kg)
_________
Height2 (m)
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
42
Standard Operating Procedure (SOP)
Use of Tiptherm ™
SOP No: .......................... ….Version: ……………………..Date:
Laboratory Manager:
C. Kolbe
Other Contacts:
B. de Jong Technical Officer
28 June 2006…………..
Ext. 16995
16885
HAZARDS:

No known hazards
PROTECTIVE
EQUIPMENT &

Nil
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU START


Wash hands in warm soapy water
Rinse well and dry completely

Hold the tip therm device against the skin on each foot in 5
different places

Ask the participant to indicate whether it is hot or cold.

Record the results


Wash hands in warm soapy water
Rinse well and dry completely
NEVER.........................
JOB STEPS
WHEN YOU FINISH
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
43
Standard Operating Procedure
(SOP)
Autonomic Nervous System Function Tests (Ewing Battery)
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
May 2006
Ext. 16995
Ext. 16995
HAZARDS
 Over-inflation of the cuff may cause minor discomfort
EMERGENCY
EQUIPMENT
 First aid kit available
BEFORE YOU START
 Wash hands in warm soapy water
 Rinse well and dry completely
EQUIPMENT NEEDED





Use a standard sphygmomanometer and cuff of appropriate size
Dynamometer
Macintosh computer, electrode leads, etc
Disposable mouthpieces
balloons





Have the participant lying down
Position the cuff and measure the blood pressure (BP)
Ask the participant to stand up
Measure at 1 minute post standing
Measure again at 3 minutes post standing
JOB STEPS
1. Blood pressure
response to standing
2. Blood pressure
response to sustained
handgrip
 Explain the dynamometer and determine maximum hand grip of
the dominant arm
 Position the cuff on the opposite arm
 Measure BP at rest
 Ask the participant to squeeze the dynamometer (30% maximum
voluntary contraction)
 Record time and BP at 1 minute intervals up to 5 minutes
Note: If the participant cannot hold for the full 5 minutes allow them to
release their grip and record tis on the sheet.
Measure of response: This is the difference between the diastolic BP
before starting and diastolic BP just before release of hand grip.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
44
3. Heart rate deep
breathing
4. Heart rate response to
standing up
5. Heart rate response to
lying
6. Valsalva manoeuvre
 Attach electrode leads as per 3 lead ECG SOP
 Allow the participant to rest quietly for 3 minutes
 Recorded the heart rate (HR) for 5 min while patient is breathing
quietly
 After a further 2 minute interval the heart rate is recorded for a
further 1 minute interval of deep breathing at 6 breaths per minute
(5 sec inspiration and 5 second expiration).
Note: All participants are to have a practice session before recording
commences. The maximum and minium heart rate for each breathing
cycle is measured and the mean of three successive breathing cycles is
taken to give the maximum-minimum heart rate.
 Measure heart rate as standing from lying position. Take 30:15
interval.
 Measure heart rate as lying from standing position. Take 30:15
interval.
Attach Pulse oximeter and check O2 saturation
# If O2 saturation < 95% and/or patient has a CVD or respiratory
condition advise clinical supervisor before continuing with this test.
 Participant sits quietly and then blows into the disposable
mouthpiece at 40mmHg for 15sec.
 Rest 30 sec and then repeat 4 times
Note: Heart rate increases normally followed by rebound bradycardia
after release. The ratio of the longest RR interval shortly after the
manoeuvre to the shortest RR interval during the manoeuvre is
measured. The Valsalva ratio is the mean of three successive
manoeuvres.
WHEN YOU FINISH
 Remove the leads from the participant
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
45
Standard Operating Procedure
(SOP)
3-lead Electrocardiogram (ECG)
SOP No: ......................................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Cherryl Kolbe
Other Contacts: Bev deJong Technical Officer
May 2006
Ext. 16995
Ext. 16995
HAZARDS:

There are no known risks associated with an ECG.
PROTECTIVE
EQUIPMENT &

nil
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU
START



Wash hands in warm soapy water
Rinse well and dry completely
Welcome the participant and introduce the staff/student members present
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
46
JOB STEPS
Software Setup
1.
2.
3.
4.
5.
6.
7.
Electrode
Attachment
1.
2.
3.
4.
5.
Recording the
ECG
1.
2.
3.
First Segment
Standing to Lying
1.
2.
3.
4.
5.
6.
Turn on the Macintosh computer
Double click on the desktop icon ‘Diabetes 3 lead ECG’ to open Chart V3.6
Click on Setup > Channel Settings
Reduce the number of channels to 1
Click on Bioamp and enter the following settings
Range
1MV
Notch
ON
High Pass
0.3 Hz
Low Pass
50 Hz
Click on OK
Click on OK to close the channel settings window
Ask the participant if they have any allergies to bandaids or alcohol wipes.
To ensure a stable artefact free ECG the skin should be properly prepared. Remove any
hair at the electrode site and clean the area with an alcohol wipe. Allow to dry.
Attach the electrode leads to the disposable electrodes prior to placement on the
participant.
The ECG leads should be positioned as shown in the following diagram. Peel the
electrodes off the card and attach to the participant.
(R) clavicle
neg electrode
(L) hip
pos electrode
(R) hip
ground
Make stress loops with the leads and attach firmly to the skin with micropore tape. You
will be shown how to do this.
Ask the participant to stand relaxed in front of the bed with their arms to the side and
explain to them the series of recordings and what they are expected to do. ie. Remain
still and quiet.
Click on start and ensure the trace is free of noise. It is essential to have a noise-free
recording – if there is noise in the recording check the electrode attachments. This is
usually the reason.
When satisfied with the trace click on Stop.
Click on File > New > Don’t Save. This will open a new recording.
Click on Start
Record for 30 secs & then insert a marker by double clicking on Stop (this also restarts
the timer)
Ask the participant to lie down and continue the recording for another 30 secs.
Click on Stop.
Click on File > Save As > and then enter the file name: SL_code name_date eg
SL_KOLC220253_300506
7.
8.
Select windows data file which adds the code adicht
Click on Save
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
47
Second Segment
Lying
1.
2.
3.
4.
Click on File > New
Click on Start
Record for 20 mins. Don’t forget to set your timer.
Click on Stop > File > Save As and then enter the file name: 20min_code name_date
eg
20min_KOLC220253_300506
Third Segment
Lying to Standing
5.
6.
Select windows data file which adds the code adicht
Click on Save
1.
2.
3.
4.
5.
6.
7.
Click on File > New
Click on Start
Record for 30 secs, then insert a marker as before
Ask the participant to stand (ensure they aren’t light headed on standing)
Continue the recording for another 30 secs
Click on Stop.
Click on File > Save As > and then enter the file name: LS_code name_date eg
LS_KOLC220253_300506
8.
9.
10.
11.
12.
WHEN YOU
FINISH


Select windows data file which adds the code adicht
Click on Save
Click on File > New
Now you are ready for the next participant
Remove the electrode leads and disposable electrodes from the participant and check
that all the adhesive is removed
Wash hands
Now you are ready for the next participant
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
48
Standard Operating Procedure
(SOP)
12-lead Electrocardiogram (ECG)
SOP No: ......................................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Cherryl Kolbe
Other Contacts: Bev deJong Technical Officer
May 2006
Ext. 16995
Ext. 16995
HAZARDS:

nil
PROTECTIVE
EQUIPMENT &

nil
EMERGENCY
EQUIPMENT

First aid kit available
BEFORE YOU
START



Wash hands in warm soapy water
Rinse well and dry completely
Welcome the participant and introduce the staff/student members present
JOB STEPS

Give the participant a brief outline of the procedure
 12 lead ECG to test the heart describing the electrode placement to them
 Explain that ECG measures “the electrical wiring” (most people will relate to
pacemaker) of the heart, emphasise that the process does not apply any
electrical stimulation.

Enquire if the participant has previously undergone a 12 lead ECG recording

Ask the participant if they have a sensitivity to bandaids or adhesive plaster – record on
sheet

Ask the participant to remove their undergarments and replace their outer shirt leaving it
untucked and unbuttoned at the front. They may then lie down. Ensure that the area is
enclosed for privacy
Note: Students should leave the room while the participant is undressing.


To ensure a stable artefact free ECG the skin should be properly prepared. Using a
disposable razor remove any hair at the electrode site and clean the area with an
alcohol wipe. Allow to dry.
Ask permission to feel along the ribs prior to electrode placement
Electrode Placement:
Apply the precordial electrodes as outlined below:
V1: In the fourth intercostal space at the right sternal border.
V2: in the fourth intercostal space at the left sternal border.
V3: mid-way between V2 and V4.
V4: in the fifth Intercostal space in the mid-clavicular line.
V5: in the left anterior axillary line at the level of V4.
V6: In the left mid-axillary line at the level of V4.
(Directly under the midpoint of the armpit)
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
49
Note: It is essential to be discrete whilst placing precordial electrodes on women. If practical,
leave the breasts covered.

Attach the limb leads appropriately to the ankles and wrists.

Ask the participant if they are in a comfortable position and require a blanket or a pillow
under their knees if they experience back pain.
Recording ECG

Double click on the CardioPerfect desktop icon

Enter the word ”admin” as the password and click on
to open the program
10 Second Recording

Click on File > New> Patient

The PatientCard window will appear

Enter information as shown in the figure below (eg patient code_length of
recording_date)

Click OK

Click on

The New ECG window should appear
> ECG
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
50


Click OK
The recording window will appear



When the trace has stabilised, click on
Turn off the recording device when prompted
The recording will automatically be saved
5 Minute Recording

Click on File > New> Patient

The PatientCard window will appear

Enter information as shown in the figure below (eg patient code_length of
recording_date)

Click OK
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
51

Click on

The New ECG window should appear


Click OK
The recording window will appear
> ECG
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
52
WHEN YOU
FINISH





When the trace has stabilised, click on
Turn off the recording device when prompted
The recording will automatically be saved

Remove the electrode leads and disposable electrodes from the participant and
check that all the adhesive is removed
Wash hands
Now you are ready for the next participant
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
53
Risk Assessments
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
54
RISK ASSESSMENT
Venipuncture
Name and status of Assessor: C. Kolbe
Senior Technical Officer
Date:
2.4.01
1.
Introduction
An “Exposure prone procedure” (EPP) is a term usually characterised by any situation where there is a
potentially high risk of transmission of a blood borne disease from a worker to a patient (or vice versa) during a
medical procedure. Venipuncture is a procedure where there is this potential for direct contact between the skin
(usually finger or thumb) of the blood collector and a sharp surgical instrument such as a needle.
It is essential that realistic assessments are made of the likelihood and severity of any injuries arising from
venipuncture. Both physical and psychological risks must be assessed.
2.
c)
d)
3.
a)
b)
c)
d)
4.
a)
b)
Risks
Ethical issues
 Subjects should not feel they have been abused as a result of venipuncture. This could include excessive
pain or discomfort and embarrassment or humiliation.
Physical Risks
 Patient experiencing nausea, light-headedness, dizziness, fainting
 Needlestick injury
Control Measures
Inform the patient of the possibility of discomfort or embarrassment.
Have available the following first aid measures:
first aid kit
first aid officer
emergency phone numbers near the most accessible phone
Only suitably qualified and experienced staff may perform venipuncture
Those performing venipuncture must comply with the following Physiology Laboratory Guidelines:
Venipuncture
Medical Emergencies
Infection Control
Emergency Procedures
There must be a First Aid / CPR trained person available in case of an emergency.
Emergency procedures must be in place – refer to Charles Sturt University Physiology Laboratory “Guidelines
for Medical Emergencies”
5. Remaining Risk
If the control measures outlined above are maintained, the risks will be reduced considerably.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
55
RISK ASSESSMENT
Electrocardiogram (ECG)
Prepared by:
C. Kolbe
Senior Technical Officer
Adoption Date:
7 March 2001
An electrocardiogram, or ECG, records the rhythm and electrical activity of your heart.
Several small electrodes are attached to the arms, legs or chest and connected to an ECG recording device.
The electrodes are connected to electrode leads which are connected to the ECG recorder. This recorder
picks up the electrical signals produced by each heartbeat and prints out the recording onto paper. The ECG
device only records signals from the body. It does not give electric shocks and does not affect the heart in
any way. The entire test takes several minutes and there is no discomfort.
1. Hazards
 An ECG is a safe, painless test that provides no discomfort to the patient. There are no known risks
associated with an ECG.
2. Precautions


Hair may sometimes need removal to allow for correct attachment of the electrodes. This will only
be performed with a single use razor.
Electrodes must be firmly attached to the chest to permit accurate recording of the heart's activity.
3. Training Requirement
 All persons performing an ECG will be appropriately trained and their training recorded.
4. Level of Risk Remaining
 There are no known risks associated with performing an ECG.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
56
RISK ASSESSMENT
Blood Pressure Recording using a Sphygmomanometer and Stethoscope
Prepared by:
C. Kolbe
Senior Technical Officer
Adoption Date:
7 March 2001
The usual method of measurement of blood pressure is a non invasive means that uses a
sphygmomanometer, which includes either a column of mercury or pressure-registering gauge. With this
technique, the flow of blood is temporarily stopped by an inflated cuff that is wrapped around the upper arm
and that puts pressure on the main artery in the arm. Blood flow is then gradually restarted as the user
slowly deflates the cuff.
1. Hazards
 Exposure to mercury from a broken sphygmomanometer.
 Over-inflation of the cuff
2. Precautions


Precautions must be taken to limit the inhalation, ingestion or absorption of mercury in case of a spill
or breakage. Mercury is a silver-coloured metallic element that is liquid at room temperature and
tends to break into tiny, highly mobile droplets when spilled. These droplets vaporize and can
contaminate the atmosphere. Exposure to mercury from sphygmomanometers used in health-care
settings is extremely rare.
Selecting appropriately sized cuffs is critical. The appropriate cuff width is based on the diameter of
the upper arm. Taking blood pressure measurement with a cuff that is too narrow could
overestimate blood pressure, while too wide a cuff can underestimate the pressure.
3. Training Requirement
 All persons performing blood pressure measurements will be appropriately trained and the training
recorded.
4. Level of Risk Remaining
 If due care is taken the level of risk remaining is low.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
57
RISK ASSESSMENT
Blood Pressure Recording using a Digital Blood Pressure Monitor
Prepared by:
C. Kolbe
Senior Technical Officer
Adoption Date:
7 March 2001
Use of the digital blood pressure monitor is safe and non invasive. With this technique a cuff is wrapped
around the upper left arm and a rubber bulb is squeezed rapidly to inflate the cuff. The cuff pressure then
slowly decreases until the systolic and diastolic pressure readings are displayed. The auto inflation bulb is
then released to expel all the air from the cuff.
1. Hazards
 Over-inflation of the cuff may cause minor discomfort
2. Precautions
 Selecting appropriately sized cuffs is critical. The appropriate cuff width is based on the diameter of
the upper arm. Taking blood pressure measurement with a cuff that is too narrow could
overestimate blood pressure, while too wide a cuff can underestimate the pressure.
3. Training Requirement
 All persons performing blood pressure measurements will be appropriately trained and the training
recorded.
4. Level of Risk Remaining
 If due care is taken the level of risk remaining is low.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
58
Emergency Procedures
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
59
Cedar Floor Plan
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
60
Standard Operating Procedure
(SOP)
Diabetes Complications Screening Emergency Response
SOP No: ................................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Cherryl Kolbe
Ext. 16995
Other Contacts: Bev deJong Technical Officer
Rationale:
EMERGENCY
EQUIPMENT
JOB STEPS
Conscious patient with
chest pain and or
difficulty of breathing
Unconscious Patient
Breathing
Unconscious not
breathing
WHEN YOU FINISH
May 2006
Ext. 16995
Given the number of participants enrolled in the screening program and
their co-morbidities including diabetes, cardiovascular disease including
hypertension and diseases associated with aging the emergency
response below has been developed in the event of a medical
emergency.




Telephone
First aid kit
Resuscitation Equipment
List of First Aid Officers
o Bev De Jong
Physiology Lab (Back Wilcara)
16858
o Tim Rowston Photography
16914
o Karen Scheetz Library
16877
o Steve Knox
Services Officer (Secutity)
16888
o Corey Fisher Services Officer (Security)
16888
These staff all have current Intermediate First Aid and CardioPulmonary Resuscitation certificates.





Put patient on a bed or chair, whichever is closer, should not be
walked, wheel chair needed.
Call for Help
Apply Oxygen at 6L via a Hudson mask
Call RN or First Aid Officer (Bev deJong) to assess the patient
Phone ambulance 000 as appropriate






Turn patient on the left lateral side
Call for help
Maintain airway and apply Oxygen 8L Hudson
to assess the patient
Call ambulance
DRABC (Check for Danger, Response, Airways, Breathing and
Circulation)
 Call ambulance 000
 Call RN or First Aid Officer (Bev deJong)
 Perform CPR as appropriate
Note: In service will be provided by Paul Warner to communicate this
procedure to staff and students involved in the Diabetes Complications
Screening program.

Make sure an accident/Incident report is completed
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
61
Standard Operating Procedure
(SOP)
Hypoglycaemia Emergency Response
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
2004
Ext. 16995
Ext. 16995
SIGNS & SYMPTOMS:











Excessive sweating
Shanking and/or trembling
Feeling faint
Headache
Blurred vision
Irritability
Extreme hunger
Racing / pounding heart
Personality change eg aggression
Lethargy and/or drowsiness
Coma / fitting
EMERGENCY
EQUIPMENT


First aid kit available
Resuscitation equipment
JOB STEPS for the
CONSCIOUS PATIENT


Perform a blood glucose test
If < 5mmol/L administer quick acting sugar in the form of:
o 5-7 jelly beans
o warm sugary drink (eg tea or coffee)
o ½ can of regular soft drink
o fruit juice
After several minutes redo the blood glucose and administer
long acting carbohydrate in the form of:
o 2 sweet biscuits
o bread
o fruit
After 30 minutes redo the blood glucose which should be >
5mmol/L


JOB STEPS for the
UNCONSCIOUS PATIENT






Call 000 and remain with the patient
Do not administer anything by mouth
Position patient on the side
Clear the airway
Tilt the head slightly and support the jaw
Check vital signs
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
62
Standard Operating Procedure
(SOP)
Fainting Emergency Response
SOP No: .......................... ….Version: ………1.0……………..Date:
Laboratory Manager:
Other Contacts:
Cherryl Kolbe
Bev deJong Technical Officer
2004
Ext. 16995
Ext. 16995

Fainting may be caused by nervous excitement (venipuncture).
The victim looks shocked, feels faint and giddy and may
collapse.
EMERGENCY
EQUIPMENT


First aid kit available
Resuscitation equipment
JOB STEPS











Lay the patient down if not already on the floor
Raise both legs
Loosen any tight clothing at the neck and waist
Apply a cool towel to the head
Apply Oxygen if available – Hudson mask @ 6-8L/min
Check for pupillary response
Ventilate room
Reassure the patient if awake
Do not give food or drink until the patient has recovered fully
Assist the patient to a seated position when they feel ready
Assist the patient to a standing position when they feel ready
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
63
Student Screening Documents
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
64
Student Acknowledgement Statement
I have read and understand the emergency guidelines for the Diabetes Complications
Screening and Research.
I understand the information and data collected during the Diabetes Complications
Screening and Research at Charles Sturt University is strictly confidential.
I will, under no circumstances, discuss any of the information I may come in contact with
while participating in the Diabetes Complications Screening and Research.
I understand that I can elect not to participate or allow my results to be used in the
Diabetes Complications Screening and Research.
I understand that my participation as part of my course work requirement is
acknowledged.
Name:
Signature:
Date:
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
65
Student feedback for diabetes complications screening
Course enrolled in:
Year of course
Have you had any professional health care experience before starting your university
course?
If yes above, what did you do?
Describe the most interesting/relevant experience you gained during your placement with
the diabetes complications screening.
Has your participation in the diabetes complications clinic helped you clarify your
understanding of the role of your profession within diabetes health care?
If yes above, elaborate please.
What do you understand research to involve?
Are you interested in research?
What do you understand research to imply within your profession?
Has your participation in research helped you clarify your understanding of the role of
research in the nursing profession?
Describe the most interesting/relevant experience you gained during your research
project.
Describe the most irrelevant experience you gained during your research project
Can you see any relevance of the research project you participated in to everyday health
care in your profession?
If so, explain.
If not, explain.
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
66
Diabetes Complications Screening Forms
S:\common\Temp Folder Less Than 60 Days\Student diabetes screening\Complete
doc(190706).doc
67
Charles Sturt University
School of Community Health
PO Box 789
Albury NSW 2640
Tel (02) 6051 6000
Information Sheet
Diabetes Complications Screening Project
You are invited to participate in a student education / research project of complications
associated with diabetes such as heart disease, eye and foot disease. This study is being
conducted by Dr Herbert Jelinek and includes several clinicians and scientists associated with
Charles Sturt University as well as other local physicians, national and international research
institutions. Podiatry students will be on placement and nursing students will be attending as
part of their course work requirements. In addition postgraduate students may be in attendance.
The main purpose of the study is to determine whether regular screening is of benefit to the rural
community and contribute research output including automated procedures for detection of
changes in the eye and heart associated with diabetes as well as identifying early changes in
blood constituents that allows risk assessment for diabetes and cardiovascular disease. We
invite you to continue to participate annually to assess your heart, eye and foot health as well as
blood pressure and other health indicators.
If you decide to participate in this research you will be asked to complete a questionnaire about
your general medical history and medications. You may also be invited to participate in a
related study investigating your use and attitudes towards complementary medicines. You will
have a series of clinical tests for the following diabetes complications.
Please note that the screening will provide feedback of most results to you. However the results
can not be seen as a clinical diagnosis and should be confirmed by your general practitioner.
Blood: 20 ml will be collected via venipuncture for biochemical tests including markers of
oxidative stress and glucose.
Heart: Blood pressure will be recorded whilst lying and standing. A 12-lead ECG recording
lasting for 5 minutes. A 3-lead 20 minute recording – this will commence whilst standing
followed by 20 minutes of lying down and a final small recording taken immediately upon
standing again. The ECG recording involves attaching sensors to your skin. It may be necessary
to clean a small area of skin, with an alcohol swab and/or shaving, to ensure the sensors are
attached properly. Whilst your ECG is recorded we will also record your oxygen saturation in the
blood. The main risk with the ECG recording is temporary dizziness when you move from lying
to standing, similar to getting out of bed too quickly. In order to prevent any problems you will be
monitored and assisted throughout and following the recording. If any abnormality is detected in
your ECG recording you will be informed and we will suggest you contact your GP.
Autonomic Nervous System Function Tests: several tests may be done including blood
pressure response to a sustained handgrip (30% maximal), heart rate monitoring whilst deep
breathing and performing the Valsalva manoeuvre (breathing out forcefully five times) If you
have a known heart or respiratory problem you should not take part in the Valsalva test.
Eyes: a photo is taken of the retina of each eye. The flash may momentarily blind you and you
may see a blue halo. This disappears within 10 minutes from the photo being taken. The
photograph is then assessed by an ophthalmologist at the Albury Eye Clinic and you will be
informed if there is any abnormality detected. There is no recorded risk associated with this
procedure however if you have a cataract or other eye disease please inform the technician
taking photographs.
Feet: You will be asked to complete a foot health and claudication. Clinical tests are for
sensation response of the feet and we will take blood pressures at each ankle for comparison
with each arm. This is a common test for peripheral vascular problems in diabetes and is known
as the ankle brachial index (ABI). The second test determines your pulse pressure in your ankle
and requires a velcro band to be placed around your ankle for five minutes. We do not expect
you to have any discomfort with these procedures apart from a short increase in pressure
experienced at the arm and leg. A pulse pressure test may also be carried out which involves
placement of a small Velcro band around the index finger and big toe whilst we record the
changes in blood flow. The band does not exert any pressure on your finger or toe.
Glucose tolerance test: specially selected participants who agree to partake in glucose testing
will be asked to drink Glucaid solution (75g glucose in 300ml), finger prick tests for BGL and a
urine sample will be collected at half hourly intervals until BGL levels return to normal. Those
with diabetes will require clearance from their GP for participation.
Health Care for people with diabetes: There will be a number of medical students from the
University of New South Wales Rural Clinical School present that may interview you on your
opinion on how well your diabetes is currently managed.
The entire assessment should take approximately 2 1/2 hours. The data collected will be stored
on computer before being analysed. Once analysed a portion of the results of the study may
form part of research projects undertaken by honours and postgraduate students. Currently Mr
Uba Nwose’s Doctor of Philosophy thesis is based on blood constituent information. It is also
planned to publish the results in several medical journals. A strip (small section) of an ECG or
pulse wave recording may also be published, however any data used will not have any
identifying features. The data collected may also be used in future research with other
collaborators. In future research the same processes for confidentiality will be adhered to.
Your confidentiality will be maintained at all times, and all data will be depersonalised using a
code. Accordingly in any publication, information will be provided in such a way that you cannot
be identified.
You do not have to participate in this study and can withdraw from the project at any time.
NOTE:
The Charles Sturt University’s Human Ethics Committee has approved this project .
If you have any complaints or reservations about the ethical conduct of this project, you may
contact the Committee through:
The Presiding Officer, Charles Sturt University Human Ethics Committee Ph. 02 63384185
Any issues you raise will be treated in confidence and investigated fully and you will be informed
of the outcome.
Charles Sturt University
School of Community Health
PO Box 789
Albury NSW 2640
Consent Form
Title of research project
Diabetes Complications Screening and Research
Principal investigator
Herbert Jelinek
School of Community Heath
CSU
PO Box 789 Albury
6051 6946
1. I, ……………………….……………………consent to my participation in the research project
“Diabetes Complications Screening and Research”.
2.
I understand that I am free to withdraw my participation in the research at any time
3.
The purpose of the research has been explained to me and I have read and understood
the information sheet.
4.
I understand that students will be involved in the data collection and consent students to
undertake the diverse tests as required and outlined in (5) below.
5.
I permit the investigator or students to take Blood pressure measurements and a blood
sample, Eye photographs, Range of motion measurements, ECG and pulse wave recordings as
part of this project. As well as measure blood pressure whilst lying and standing, having a
clenched fist and breathing deeply.
6.
I understand that any information or personal details gathered in the course of this
research about me are confidential and that neither my name nor any other identifying information
will be used or published without my written permission.
7.
I understand that any data gathered in the course of this research may be published
and/or used in subsequent research projects.
8.
I understand that the feedback provided to me consist of data collected as part of the
research project and is not a clinical diagnosis. Clinical information regarding the feedback can be
provided by my general practitioner
9.
The Charles Sturt University Human Ethics Committee has approved this study. I
understand that if I have any complaints or concerns about the research I can contact: Dr Herbert
Jelinek on 60516946.
10.
I agree that CSU can access my general practitioner / pathology for results relevant to
diabetes and cardiovascular disease screening.
GENERAL PRACTITIONER:
Name…………………………………….
Address…………………………………
Phone no………………………………..
………………………………………………
Signature of participant
………………………………………………
Name (Please Print)
………………………………………………
………………………………………
Signature of witness
…………………………………………
Name (Please Print)
…………………………………………
Date
Date
………………………………………….
………………………………………….
PHONE NO:
………………………………………….
*required to send heart and eye assessment results
Contact Address*
Charles Sturt University
School of Community Health
PO Box 789
Albury NSW 2640
Diabetes Complications Screening and Research
Participants Information
The following questionnaire is designed to find out some information about your medical history in relation to
the study. This information is required so the data can be comprehensively analysed. Your confidentiality will
be maintained at all times.
Date ……………….. Male / Female
DOB…………………………….
…………….years
Age
Have you been diagnosed with diabetes?................
Type I [ ] or
Type II [ ]
Number of years diabetic ………
Do you take insulin? ………………..
If yes, what type and what dosage?.....................................................................................................
Have you been diagnosed with or are you taking medication for, any of the following? Please tick

Cardiac problems eg Angina [ ], heart failure [ ],
atrial fibrillation [ ], heart attacks [ ] Other [ ]
 Reflux
 Kidney problems
 Bladder problems
 Retinopathy (eyes)
 Ulcers on the legs and feet
 Glaucoma (eyes)

 Stroke
Pain [ ], numbness [ ], tingling [ ] or loss of
sensation [ ], cold [ ] or burning [ ] in feet
 Increased sweating
 Epilepsy
What are your current prescription medications? (Please include dose)
…………………………………………………………………………………………………….
Have you had any hospitalisations? (If attended clinic previously since last attendance). Provide reason.
…………………………………………………………………………………………………….
Have you had any changes to your medication within the last month prior to this study? Please list.
…………………………………………………………………………………………………….
Have you experienced any dizziness [ ], palpitations [ ] or pain in the chest [ ] or left arm [ ]?
…………………………………………………………………………………………………….
Do you have a Department of Veterans Affairs card?
Yes
No
The following measurements are important has they influence heart and blood vessel function

Do you smoke more than 5 cigarettes per day


Do you consume more than 2-3 glasses of alcohol per day
Have you been told by a health professional (GP, nurse, clinician)
that you have/had High Blood pressure?
Are you currently taking medication for High Blood Pressure?
Do you have a family history of diabetes



Are you currently following a diet?
How much exercise would you participate in, in a typical week?
(please circle the correct answer) HRS/WEEK
Yes [ ] No [ ]
Yes [ ] No [ ]
Yes [ ] No [ ]
Yes [ ] No [ ]
Yes [ ] No [ ]
Yes [ ] No [ ]
None low moderate high
0 1 2 3 4 5 6 7 8 9 10+
GP PATHOLOGY ENQUIRY:
DATE OF LAST PATHOLOGY TEST (if applicable)………………………
1. When did you last see*:
your General Practitioner?………………………….
a physician?……………………………….……….
an ophthalmologist?.........................…………………
a Podiatrist?.....................................…………………
a diabetes educator/community health centre………..
* Provide time elapsed since last visit (eg 2 months)
2. If you have diabetes or cardiovascular disease. How often did you see any of the above
health professionals within the last year with respect to your diabetes/cardiovascular
disease?
…………………………………………………………………………………
…………………………………………………………………………………
…………………………………………………………………………………………………………
…………………………………………………………
3. When visiting your GP for a diabetes related consultation, did
following diabetes complications?
Eye……………………………… Yes [ ]
Listen to the heart sounds ...…… Yes [
Foot………………………………Yes [ ]
Blood Pressure ………………… Yes [
the GP test for the
No [ ]
] No [ ]
No [ ]
] No [ ]
4. Does your GP routinely screen for any of the above regardless of the nature of the visit?
Eye……………………………… Yes [ ] No [ ]
Listen to the heart sounds ...…… Yes [ ] No [ ]
Foot………………………………Yes [ ] No [ ]
Blood Pressure ………………… Yes [ ] No [ ]
5. Have you been involved in the screening before? Yes [ ] No [
]
6. If yes, were you asked to follow up any results with your GP or other health care
professional? Yes [ ] No [ ]
How did you follow up?......................................................................................
What was the outcome?…………………………………………………………
If after completing this part of the questionnaire you have any concerns please let the researcher
know and you will be provided with options for seeking further information.
Thank you
Charles Sturt University
School of Community Health
PO Box 789
Albury NSW 2640
Tel (02) 6051 6000
Participants Assessment Results Feedback
To: General Practitioner
Re: Allied Health Clinic, CSU diabetes screening results
PARTICIPANT’S NAME:
PARTICIPANT CODE:
The Diabetes Complications Research Project at Charles Sturt University offers to the public a
free screening for complications associated with diabetes as part of an ongoing research study.
The test results include finger prick for random blood glucose level, lying to standing blood
pressure, Ankle Brachial Index for peripheral vascular disease, sensory testing of the feet for
sensory neuropathy, body mass index as an indicator of increased risk of cardiovascular disease
and diabetes and a 12 lead ECG 10sec trace. Non-mydriatic colour photographs are also taken
of the optic fundus. Tests are carried out by CSU investigators and students. All results are
obtained with optimum care, however the results are not intended to take the place of a regular
review by your general practitioner
Blood Glucose
Blood glucose was measured.
Blood Glucose Result:
Normal values for fasting are levels below 7 mmol/l and for non-fasting (having something to eat
within two hours) below 11 mmol/l. A pre-diabetes condition is associated if fasting Blood Glucose
levels are greater than 5.5mmol/L but below 7mmol/L
Early morning fasting reading (if applicable) ………… Screening reading………..Time since last
meal …………….
Follow-up:
Body Mass Index (BMI) and waist circumference measurements
The body mass index (BMI) is a risk factor for cardiovascular disease and diabetes. It is
considered normal if the score is below 25. Overweight is associated with a value between 25 and
29.9, whereas obese is a value greater than 30. The BMI is determined as a ratio between weight
and height2. Waist circumference measurements regarded as normal are less than 80/94cm
female/male whilst measurements above 90/102cm female/male are regarded as indicative of
substantially increased risk to health.
BMI Result:
kg/m2
Waist circumference
cm
Follow-up:
Ankle-Brachial-Index (ABI)
The ABI is a measure that compares the blood pressure in the arm with that in the leg. As such it
is an indicator of how well blood moves down into the legs.
Result of ABI-
Right side:
Left side:
The normal range for ABI is between 0.9 and 1.3.
ABI follow up:
Peripheral Neuropathy
We also tested for how well the sensory nervous system functions in the foot. Clinical significance
is considered when bilateral changes are evident or 2 or more of the tests show changes
indicative of decreased function.
Monofilament:
Vibration:
Reflexes:
Muscle tone:
Follow – up:
Autonomic Nervous System Assessment:
Assessment of your Autonomic Nervous System is:
Blood Pressure:
a)
Lying (average of two readings) Systolic:
b)
Standing at 2 minutes Systolic:
c)
Difference:
Systolic:………..
Diastolic:
Diastolic:
Diastolic:…………..
A blood pressure of 120/80 is normal but can be up to 140/90. Please note if there is a drop of
systolic blood pressure on standing greater than 30 mmHg or diastolic pressure greater than 15
mmHg, then this may be due to antihypertensive medication or a sign of postural hypotension.
Follow-up:
ECG Assessment: (trace of 10sec ECG provided)
Assessment of your ECG has indicated: see interpretation on ECG trace
……………………………………………………………………………………………………...
………………………………………………………………………………………………………
Note: It is not uncommon for healthy people to show some anomaly to normal sinus rhythm on
their ECG trace due to aging or because they are sports active, slim or large. Most often we see
left ventricular hypertrophy and bradycardia in ECG traces. However, these findings are often
associated with fitness. Left axis deviation is also often seen and is in some cases a marker of
heart disease. It is clinically not significant in the majority of people.
If any of your results indicate some clinically significant abnormality, we recommend that you visit
your general practitioner for a check up.
We would also appreciate if you could write us a letter letting us know of what you thought of the
diabetes screening clinic you attended and any further outcomes from follow-up with your general
practitioner.
If you have any further questions or comments you can contact Herbert Jelinek on 02 60516946
With thanks from the Diabetes Research Group.
Herbert Jelinek. PhD
Coordinator
Diabetes Complications Screening & Research
Clinical Educator
Name:
Signature:
Charles Sturt University Participant Code………….
Diabetes Screening Session - Stations.
STATION 1.
tick or n/a
[
] Consent form completed
[
]
Health/Foot Questionnaire (new clients only)
[
]
Recent GP Pathology done
[
]
Autonomic Nervous System Function test.
STATION 2.
FOLLOW UP BY D.E. [
]
Diabetes: Type I [ ] Type II [ ] N.D. [ ]
Early morning glucose ……………… mmol/L
Time since last meal ………………hrs
Clinic Glucose Test………………. mmol/L
Waist circumference………………..cm
Height…………m Weight……………kg
BMI…………………(W/h2 ; kg/m2)
Signed…………………………………
Signed…………………………………
STATION 3.
FOLLOW UP
[
]
Neuropathy
Monofilament
L[
]
R[
]
Muscle
L[
]
R[
]
Vibration
L[
]
R[
]
Reflex ankle
L[
]
R[
]
Reflex knee
L[
]
R[
]
wnl = within normal limits, p = present, a = absent
r = reduced
Signed…………………………………
STATION 4.
FOLLOW UP
[
]
A.B.I.
R. arm……/………R. leg……/…….R.ABI…………
STATION 5.
FOLLOW UP
3 lead ECG Test - (SL) / 20min / (LS)
Skin sensitivity yes [ ] no [ ]
Dizziness upon rising yes [ ] no [
ANS test done: deep breathing yes [
Valsalva
yes [
Hand grip
yes [
LS / SL
yes [
Signed…………………………………
STATION 6.
FOLLOW UP
[
]
Eye Test.
epilepsy?
Last eye test …………………………………….
Eye problems/history (glaucoma, cataracts, D.R.)
…………………………….
……………………………………………………
STATION 7A.
12 lead ECG Test
FOLLOW UP
[
]
]
]
]
]
REFERALS
DIABETES
PODIATRY
BLOOD PRESSURE
ECG
BMI
[
[
[
[
[
Average
no
no
no
no
ABI……….
Signed…………………………………
]
[ ]
[ ]
[ ]
[ ]
Signed…………………………………
[
Skin sensitivity
yes [ ] no [ ]
Previous heart problem………………………
Chest pain …………………………………...
Signed…………………………………
L. arm……/……….L. leg……/……..L.ABI…………
]
STATION 7B.
FOLLOW UP
Lying to Standing B. P.
Lying 1………/…
Lying 2………/…
Standing 1(1 min)………/..
Standing 2(3 min)………./.
Dizziness upon rising yes [ ] no [
[
]
Signed…………………………………
IMMEDIATE
]
]
]
]
]
[
[
[
[
[
RECOMMENDED
]
[
]
[
]
[
]
[
]
[
NOT REQUIRED
]
]
]
]
]
]
Station Requirements:
Podiatry
 1 Doppler
 1 aneroid sphygmomanometer
 1 stethoscope
 1 tube ultrasound gel
 Calculator
 1 Reflex hammer
 1 Monofilament
 1 Vibration tuning fork
 Gloves
 Tissues
 Rubbish bags
Extra requirement:
 1 pillow
 Viraclean solution
 Rubbish bin
3 Lead ECG
 Red dot electrodes 3M 2560
 Kimwipes
 Micropore
 Razors
 Stopwatch
 Spare rubbish bags
 Sharps container
 Extra requirements:
 2 pillows
 1 blanket or sheet
 1 rubbish bin
12 Lead ECG
 Laptop computer
 HP Printer
 Cardiocontrol unit incl unilink cable & leads
 Electrodes (red dot 3M2330)
 Printer cables
 Power board
 4 port USB2
 Razors (single use)
 Isowipes
 Micropore tape
 Timer
 Sharps container
 Tissues
 Sphygmomanometer aneroid
 Stethoscope
 9V battery
 printer cartridge HP27
Extras
 printer paper
 2 pillows
 1 blanket
 1 rubbish bin
Pathology Request Forms
Dorovitch Release Form
Dorovitch Pathology
Unit 1/2 Ramsay Place
Albury West 2640
22/02/06
To whom it may concern,
The Charles Sturt University, School of Community Health has been investigating
cardiovascular complications associated with diabetes.
The attached people have been participating in our research.
They have indicated to us that they have had pathology tests in the last 12 months and
have given consent for their results to be released to us.
Would you please forward on copies of routine chemistry, (plasma and urine) HbA1c,
Lipids and Homocysteine reports if available that these patients have had since February
2005.
Please forward results to Sharon Newbold School of Community Health Charles Sturt
University Albury.
Yours truly,
Bev deJong (60516858)
For
Dr H Jelinek
Diabetes Complications
Research Coordinator
Ph 60516946
South West Pathology Release Form
South West Pathology Service
590 Smollett St
Albury 2640
23/02/06
To whom it may concern,
The Charles Sturt University, School of Community Health has been investigating
cardiovascular complications associated with diabetes.
The attached people have been participating in our research.
They have indicated to us that they have had pathology tests in the last 12 months and
have given consent for their results to be released to us.
Would you please forward on copies of routine chemistry, (plasma and urine) HbA1c,
Lipids and Homocysteine reports if available that these patients have had since February
2005.
Please forward results to Sharon Newbold School of Community Health Charles Sturt
University Albury.
Yours truly,
Bev deJong (60516858)
For
Dr H Jelinek
Diabetes Complications
Research Coordinator
Ph 60516946
Insurance
ECG Analysis
12-lead ECG classification
Class 1a
Sinus
rhythm
Class 1b
Left
ventricular
hypertrophy
Sinus
arrhythmia
Slow rhythm
(50 > HR <
60)
Conduction
delay of atrial
or ventricular
origin
Left or right
axis deviation
Q waves
indicating old
infarct
Class 2a
1 heart bock
Notched or
enlarged P
wave(P mitrale/P
pulmonale
Peaked T waves
PVC and PAC
Right Bundle
Branch Block
Left anterior
fascicular block
(LAFB)
Right anterior
fascicular block
(RAFB)
Class 2b
Q waves in
more than 1
lead
Extensive
Inverted T
waves
Class 3
Atrial Fibrillation
Prolonged
QT interval
Left bundle
branch block
Bigeminy or
trigeminy
2 Degree
heart block type
2
Multifocal
PVC or PAC
2 Degree
heart block
type 1
ST elevation
in > 2 lead
Atrial flutter
Tachycardia
100 > HR <
120
ST
depression
with LVH
Left Bundle
Branch Block
Complete atrio
ventricular
block
Bradycardia
< 50 HR
Ventricular
fibrillation
Paroxysmal
supraventricular
tachycardia
Ventricular
tachycardia
ST elevation in
more than 2
leads
Analysing HR Intervals with Chart 5
Select
SET UP
CHANNEL SETTINGS
NUMBER OF CHANNELS = 1
OK
Select HRV
ANALYSIS SETTINGS
CLICK R WAVE DETECTION…..opens R Wave detection Settings
Check threshold
Enter value = 0.05
This will insert a line into the graph, hold pointer over
horizontal line then click and drag to a point above the highest
wave but below the lowest R wave
Check Post event sleep
OK
OK (to close boxes)
Enter value = 0.1
Select HRV
CALCULATE
Each beat shall now have a value for HRV in ms
Click on (-) button (bottom left corner) until trace is easily viewed
Click on small trace button on bottom RHS horizontal bar until relevant sections of trace
are in view (ie pre / post marker line for changed status)
Highlight section to be analysed by clicking and dragging around area
Open DATA PAD
by clicking Show Data Pad button (8th) or select from WINDOW menu
Click on heading A (Data Pad Column A Setup)
Select CYCLE VARIABLES
MINIMUM PERIOD
CHANNEL 1
OK
Click on heading B (Data Pad Column B Setup)
Select CYCLE VARIABLES
MAXIMUM PERIOD
CHANNEL 1
OK
RECORD RESULTS
T
Downloading Files from Mac Computers
Insert formatted floppy disk to computer
Open “untitled” file on desktop
Open saved files – ie DS OCT 06
The saved files should be in *.adicht format (if not open in Chart program and resave as a
‘chart for windows’ OR ‘Chart (win) data’ file
Click and drag saved file into untitled window
When disk is full drag down to the Trash to enable removal of disk
Save in
S:\Academic\Health Studies\Community Health\BMS\community of scholars\HRV\2006
Create folders ie ds oct 06 within which are:
va oct 06 ds
db oct 06 ds
ls oct 06 ds
sl oct 06 ds
copy traces into relevant folders by opening explorer with FOLDERS selected: click and
drag files across
Retinal Analysis
Digital Health Care Software and Camera Loading on to PC
INSTALL DH CLIENT SOFTWARE
SECRET LOGIN
X
PASSWORD
X.X ALL UPPERCASE!
INSTALL EOS CAMERA DRIVER: EOS DIGITAL SOLUTION DISK
DESELECT EVERYTHING EXCEPT DRIVER
INSTALL
OPEN
MY COMPUTER
SELECT CAMERA ICON
RIGHT CLICK TO OPEN PROPERTIES
CLICK ON “TAKE NO ACTION“
OPEN DH CLIENT
CONFIGURE
CANON CR DGI
CANON DIGITAL CAMERA
CANON EOS CAMERA
APPLY OK
SYSTEM CONFIGURE
UPPERCASE: RAIN.BOW OK
IMAGE SELECT AN IMAGE TYPE ie JPG OR TIF
OK
CONFIGURE
DIRECT & ARCHIVING
MAIN DB PATH
NUMBER OF COPIES
1
SHOW UNARCHIVED VISITS
YES
QUIT
TO REDIRECT FROM D:/ TO EXTERNAL HARD DRIVE:
DIRECT & ARCHIVING
ARCHIVE DEVICE: DISK
DISK ARCHIVE PATH 1: CLICK TO OPEN BROWSER
SELECT EXTERNAL HD
***EXTERNAL HD MUST BE DIRECT TO PC
LOGGIN ON REQUIRED - NO
QUIT
CAMERA STATE
JPEG – LARGE/FINE
WHITE BALANCE - DAYLIGHT
KELVIN
5400
ISO
400
SHUTTER
1/60
Non- Mydriatic Camera
SETTINGS TO REVIEW PHOTOS WITHOUT CAMERA ATTACHED
Computer ON DH Client selected with Cameras off screen displayed –
Select canon camera frame - none
frame grabber not detected – ok
USER OPTIONS:
Reset frame grabber, instrument type & video camera type to NONE
Apply
OK
Next – review patients
TO RE SET: TURN ON COMPUTER, WHEN READY TURN ON CAMERAS
Open program
Identify Patient Sheet – select Configure then User Options
Re assign:
Frame grabber:
Cannon EOS 30D
Instrument type:
Cannon CR-DGi
Video camera type: Canon Digital camera
Apply
OK
Saving Digital Eye Data as JPG Files
When photo session is completed for a participant save all photos into a file labelled EYE
jpg_DATE (create this file if necessary):
All photographs for the participant’s session should be in view
Click on photo 1 (shall be highlighted with pink outline)
Select ‘VIEW FULL SIZE’ (one click only) from the “CONTACT STRIP” drop down menu
A full screen view of the image now appears
Select “SAVE IMAGE ON DISC” from the “VIEW IMAGE” drop down menu
Select pathway – DESKTOP / EYE jpg_DATE
Save file as PARTICIPANT CODE_DATE_1 ie KOLC220253_020707_1 (number
corresponds to photograph number)
Select “QUIT”
View will return to all participant photos
Click once on photo 1 (etc) to deselect then click on next photo and repeat the above
instructions until all photos are saved